Current Medical Research and Opinion
ISSN: 0300-7995 (Print) 1473-4877 (Online) Journal homepage: http://www.tandfonline.com/loi/icmo20
A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis Paul Balter, Linda H. Ficociello, Patrice B. Taylor, Len Usvyat, Dixie-Ann Sawin, Claudy Mullon, Jose Diaz-Buxo & Paul Zabetakis To cite this article: Paul Balter, Linda H. Ficociello, Patrice B. Taylor, Len Usvyat, Dixie-Ann Sawin, Claudy Mullon, Jose Diaz-Buxo & Paul Zabetakis (2015) A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis, Current Medical Research and Opinion, 31:7, 1323-1331, DOI: 10.1185/03007995.2015.1047746 To link to this article: http://dx.doi.org/10.1185/03007995.2015.1047746
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Date: 13 November 2017, At: 00:41
Current Medical Research & Opinion 0300-7995 doi:10.1185/03007995.2015.1047746
Vol. 31, No. 7, 2015, 1323–1331
Article FT-0137.R1/1047746 All rights reserved: reproduction in whole or part not permitted
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Brief report A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis
Paul Balter
Abstract
Renal Research Institute, New York, NY, USA
Linda H. Ficociello Fresenius Medical Care North America, Waltham, MA, USA
Patrice B. Taylor Len Usvyat Renal Research Institute, New York, NY, USA Fresenius Medical Care North America, Waltham, MA, USA
Dixie-Ann Sawin Claudy Mullon Jose Diaz-Buxo Fresenius Medical Care North America, Waltham, MA, USA
Paul Zabetakis Renal Research Institute, New York, NY, USA Address for correspondence: Paul Balter MD, Corporate Medical Director, Renal Research Institute, 120 West 22nd Street, Oak Brook, IL 60523, USA. Tel: +1 630 974 5254; [email protected] Keywords: Clinical nephrology – Fluid management – Hypertension – Monitoring – Quality improvement – Volume control Accepted: 27 April 2015; published online: 2 June 2015 Citation: Curr Med Res Opin 2015; 31:1323–31
Background: Inadequate removal of extracellular volume markedly increases blood pressure and contributes to high morbidity and mortality in hemodialysis patients. Advances in fluid management are needed to improve clinical outcomes. The aim of this quality improvement project was to examine the advantages of using a hematocrit-based, blood volume monitor (Crit-Line*) for 12 months, as part of a clinic-wide, fluid management program in one dialysis facility. Methods: Forty-five individuals were receiving hemodialysis at one facility at project initiation and are included in this analysis. Monthly averaged clinical parameters (dialysis treatment information, blood pressures, blood volume, and laboratory data) were compared from Months 1–12. Analyses were conducted overall and according to the presence/absence of hypertension at Month 1 (Baseline). Antihypertensive medication changes were assessed for patients with hypertension at Month 1. Results: Average hemodialysis treatment time (þ10.6 minutes, p ¼ 0.002), eKt/V (þ0.25, p50.001) and online clearance (þ0.21, p50.0001) increased significantly in Month 12 versus Month 1. Average albumin levels and normalized protein catabolic rate increased from Month 1 to 12. Post-dialysis systolic blood pressure (SBP) decreased by Month 12 (p ¼ 0.003). In hypertensive patients (SBP 140 mmHg in Month 1), there were significant differences in pre- and post-dialysis SBP between Month 1 and Month 12 (prehemodialysis: p ¼ 0.02; post-hemodialysis: p ¼ 0.0003), and antihypertensive medication use decreased in 29% of patients, while only 11% increased use. Treatment time in hypertensive patients increased by 15.4 minutes (p ¼ 0.0005). Limitations: This was a single, clinic-wide, quality improvement project with no control group. All data analyzed were from existing clinical records, so only routinely measured clinical variables were available and missing data were possible. Conclusions: During this year-long fluid management quality improvement project, decreases in post-dialysis SBP and increases in adequacy and treatment time were observed. Patients with hypertension at Month 1 experienced reductions in pre-dialysis SBP and antihypertensive medications.
*Crit-Line is a trademark of Fresenius Medical Care Holdings, Inc. or its affiliated companies.
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Fluid management in hemodialysis Balter et al.
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Introduction
Design, setting, and duration
Volume or fluid overload is a major problem in chronic hemodialysis (HD) patients, and studies have linked volume overload to increased morbidity and mortality1. Fluid volumes 415% of the extracellular volume (ECV) (i.e., 2.5 L of excess fluid), occur in 25–28% of all HD patients2,3. Several large follow-up studies demonstrated that overhydrated HD patients have increased mortality risk compared with normohydrated HD patients4–7. ECV expansion with subsequent fluid overload may be the most important contributor to hypertension in HD patients8. At the start of dialysis, 80–90% of end-stage renal disease patients are hypertensive and have increased risk of cardiovascular disease9,10. To assist with blood pressure (BP) control, many HD patients are prescribed antihypertensive medications5. Although this approach may have beneficial antihypertensive effects, these medications can affect compensatory vasoconstriction processes, and patients might remain fluid overloaded. Thus, volume control should be an integral component of BP management and achievement of normovolemia – a key target of therapy5,11. Improvements in fluid management have the potential to positively impact clinical outcomes in HD patients12–15. Assistive technologies, including blood volume (BV) monitoring, have been employed to examine and track fluid status changes. These technologies may encourage greater focus on improving excess volume removal and fluid management12. Previous studies indicate that BV monitoring during HD could be used to assess appropriateness of target weight16–18. Some studies examined BV monitoring in clinical settings, but results have been inconsistent19–21. This report describes clinical parameter changes over 12 months of a quality improvement project on fluid management using BV monitoring as part of the daily clinic routine at one dialysis facility.
This report examines the first 12 months (April [Month 1] through March [Month 12]) of a clinic-wide fluid management quality improvement project in one Southeastern United States dialysis facility. All patients receiving dialysis at this facility were eligible for the quality improvement project. This report is limited to the patients in the facility at the quality improvement project start (n ¼ 45), allowing the establishment of baseline in Month 1 before BV monitors were installed.
Methods BV monitor used in this quality improvement project The BV monitor (Crit-Line*) used is a hematocrit (HCT) based BV monitor that is 510 k cleared to non-invasively and continuously measure percentage change in BV, HCT, oxygen saturation, and calculate hemoglobin based on HCT.
*Crit-Line is a trademark of Fresenius Medical Care Holdings, Inc. or its affiliated companies.
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Fluid management initiatives One BV monitor was installed on every HD chair during the first week of Month 2. To allow for staff training and acclimation, interventions began 1 week later for every HD treatment. Concurrent with standard of care that includes assessment of patients’ vital signs and safety parameters every 30 minutes (e.g., BP, pulse, blood flow rate, dialysis flow rate, vascular access check, signs and symptoms), staff were instructed to record percentage change in BV and HCT. At the discretion of the physician, the nurse was allowed to adjust the ultrafiltration (UF) goal up to 200 ml every 30 minutes to obtain a gradual decrease in percentage change BV, as indicated on the BV monitor. To assess whether vascular compartment refill was present at the end of HD, the UF was turned off during the last 15 minutes of the HD session. If there was a decrease in HCT of 0.5 during those 15 minutes, then the patient’s target weight could be adjusted for the next treatment. If a patient became symptomatic or hypotensive, standard clinic procedures were followed including: reducing UF goal, reducing UF to minimum for 10–15 minutes, lowering dialysate temperature from the standard of 37 to 35.5 C, repositioning patient, or administering saline. Oxygen therapy was administered if oxygen saturation fell below 90% for fistula or grafts, or below 60% for catheters. If a patient had large interdialytic fluid gains that could not be removed during the treatment, treatment length could be extended or an extra treatment scheduled. Patients were dialyzed with a 137 mmol/L dialysate sodium, unless a lower sodium concentration was ordered. Ultrafiltration profiles and sodium modeling were not used. Finally, nurses and dieticians stressed the importance of fluid and sodium restriction to the patients.
Clinical and treatment parameters The following data were routinely available from an electronic data warehouse: pre- and post-HD body weight, interdialytic weight gain (IDWG), systolic blood pressure (SBP) and diastolic blood pressure (DBP), pre-HD serum phosphorus, albumin, and normalized protein catabolic rate (nPCR); as well as information on treatment time www.cmrojournal.com ! 2015 Informa UK Ltd
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and adequacy (total eKt/V and on-line clearance [OLC]). The monthly averages for continuous variables were calculated per person. Data on antihypertensive medications were collected quarterly from patient self-reports, bottle checks, and discharge summaries by a nurse. Data recorded on the treatment sheets regarding intradialytic BP changes, symptoms, and interventions made by staff (e.g., saline administration) were reviewed for one week each month from Month 2 (first week of Month 2 after BV monitor installed, but before interventions began) to Month 9 of the project by a nurse. Symptoms during dialysis included all patient-reported discomfort such as cramps, nausea, headache, and general malaise (e.g. ‘not feeling well’). Administration of extra saline (excluding saline needed to start/end HD treatment and any flushes due to clotting or heparin-free treatments) and instances when the UF was set to off/minimum (excluding refill checks) were also recorded. For the current analysis, hypotension was defined according to the National Kidney Foundation Kidney Disease Outcome Quality Initiative (NKF KDOQI) Guidelines22 as a drop of 20 mmHg in SBP or a drop of 10 mmHg in mean arterial pressure (MAP) associated with symptoms. Symptom and SBP drop were not required to occur simultaneously, only within the same dialysis session. BV monitor data including percentage change in BV were captured electronically. Treatments with obvious errors that would impact the ending percentage change in BV were removed including: improbably low starting HCT, short duration, and technical errors (e.g., sensor clip removal/shift). Hospital admissions data were collected and these ICD-9 codes were considered possibly fluid related: 276.6, 276.69, 398.91, 402.01, 402.11, 402.91, 404.03, 404.11, 404.91, 428.0, 428.2, 428.21, 428.22, 428.23, 428.3, 428.31, 428.32, 428.33, 428.4, 428.41, 428.42, 428.43, 514, 518.4, 782.3, 786.05, 1075, 34736. Person-time for calculation of hospital rates was summed over all patients using (last HD date - first HD date)/365. Fluid-related hospital admission rates are reported cumulatively over 12 months, not monthly, due to small sample size and infrequent occurrence.
Analyses and statistical methods Descriptive analyses were performed on data from all 45 patients. Paired t-tests were used to compare clinical outcomes in Month 1 to Month 12 for patients with complete data during those months (n ¼ 36). To account for repeated observations over time on the same patients and utilize incomplete follow-up information, mixed effects linear regression modeling was used to estimate the change per month (n ¼ 45). Patients were stratified according to the presence (SBP 140 mmHg) or absence (SBP5140 mmHg) of hypertension at Month 1. To assess ! 2015 Informa UK Ltd www.cmrojournal.com
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the relation between antihypertensive medication changes and BP changes among hypertensive patients, SBP slopes across categories of medication changes were constructed and analyzed. SBP changes were assessed based on the statistical significance of SBP slope using linear regression.
Results Patient participation and demographics Forty-five patients were included in the current analysis. Thirty-six patients were observed through Month 12; three patients transferred dialysis facility, one patient moved to hospice, and five patients died. Death certificates and discharge summaries, where appropriate, were reviewed for deceased patients. Causes of death for these patients were (1) cancer, (2) chronic obstructive pulmonary disease with multiple co-morbidities, (3) pneumonia, and (4, 5) sudden death arrhythmia. There were 11 possible fluid-related hospitalizations over the year (0.28 per patient-year). Patient demographics are shown in Table 1. On average, patients were aged 59 years with dialysis vintage of 3.6 years. Fifty-six percent of the participants were male, 53% were Black or African American, and 27% were Hispanic. At the start of the project, 80% had a fistula or graft as their vascular access. The average serum sodium level was 138.8 mmol/L, and the standard dialysate sodium concentration was 137 mmol/L.
Changes in clinical parameters (all patients) Table 2 describes the monthly changes in clinical parameters for all patients. Comparisons were made between Months 1 and 12 using t-tests for the patients with data available for both months. There were significant changes in the average treatment time (þ10.6 minutes, p ¼ 0.002), post-HD SBP (-10.6 mmHg, p ¼ 0.003), eKt/V (þ0.25, p50.0001) and OLC (þ0.21, p50.0001) between Month 1 and Month 12. The average albumin levels and nPCR showed increasing trends, with average changes of 0.07 (p ¼ 0.09) and 0.06 (p ¼ 0.06), respectively. There was a trend toward serum phosphorus decreases (0.9 mg/dL, p ¼ 0.001). There was minimal overall change in percentage BV change (0.1%, p ¼ 0.89), post-HD weight (0.32 kg, p ¼ 0.6), and IDWG (0.02 kg, p ¼ 0.9). A mixed effects model was used to estimate changes per month for the complete sample (n ¼ 45). On average, estimated monthly change was 0.5 mmHg for pre-HD SBP (p ¼ 0.09), 1.4 mmHg for post-HD SBP (p50.0001), 1 minute for treatment time (p ¼ 0.002), 0.02 for eKt/V (p50.0001), and 0.01 for OLC (p ¼ 0.002). There was no statistically significant trend toward decreasing preand post-HD weights or IDWG. The monthly mean Fluid management in hemodialysis Balter et al.
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Table 1. Patient demographics and treatment parameters at baseline.
Male (%) Black or African American (%) Hispanic (%) Age (years) Dialysis Vintage (years) % with Fistula or Graft Serum Sodium (mmol/L) Dialysate Sodium (mmol/L)
All patients (n ¼ 45)
Patients with hypertension at baseline (n ¼ 28)*
Patients with normotension at baseline (n ¼ 17)**
56 53 27 59 17 3.6 3.3 80 138.8 2.7 137 0
68 54 32 58 18 3.2 2.8 86 138.6 2.8 137 0
35 53 18 60 16 4.3 4.1 71 139.2 2.5 137 0
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*Pre-dialysis SBP 140 mmHg during Month 1. **Pre-dialysis SBP 5140 mmHg during Month 1.
percentage BV changes ranged from 6.5 2.9% to 7.9 3.1% at treatment end and patients lost an average of 2.2–2.7 kg per treatment.
Intradialytic morbidity and interventions In total, 936 treatment sheets from all available treatments from one week each month were reviewed for Months 2–9. For Month 2, the week during the BV monitor acclimation period (when treatment changes were not made based on percentage change BV) was chosen, serving as the baseline. Figure 1 shows the distribution of intradialytic events and intervention recorded Months 1–8. Intradialytic hypotension and symptoms such as cramping, general malaise, or any other documented patient discomfort were variable across months and throughout the quality improvement project. The percentage of treatments for which saline was administered beyond routine dialysis initiation and discontinuation decreased compared to Month 2 (16.9%) in Months 3, 4, 5, and 9, while there was an increase in Months 6, 7, and 8. The percentage of treatments during which clinic staff turned the UF to minimum or off (not including refill checks) was the highest during Month 2 (36.9%) and lowest for Month 7 (9.6%). Thirtyseven patients (82%) experienced at least one hypotensive episode during the year.
Stratification by baseline hypertension Patients were stratified into two groups for this current report based on mean pre-HD SBP during Month 1. Twenty-eight patients had a mean SBP 140 mmHg (‘Baseline Hypertensive’) and 17 patients had a mean SBP5140 mmHg (‘Baseline Normotensive’) during Month 1. Except for differences in phosphorous levels, the Baseline Normotensive group did not show significant differences in any clinical parameters recorded (Supplemental data). In these patients, serum phosphorus levels decreased from 6.0 1.8 mg/dL in Month 1 to 1326
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4.7 1.1 mg/dL in Month 12 (p ¼ 0.01). In 10 of the 12 months, phosphorus levels were within the KDOQI recommended range of 3.5–5.5 mg/dL (1.13 and 1.78 mmol/L). Table 3 describes monthly changes in clinical parameters in the Baseline Hypertensive group. Comparisons were made between Month 1 and Month 12 using t-tests for the Baseline Hypertensive patients with data from both months. There were significant increases in the average dialysis treatment time (15.4 minutes, p ¼ 0.0005), the average eKt/V (0.28, p ¼ 0.0002), and average OLC (0.22, p ¼ 0.0001). There were significant decreases in the pre- and post-HD SBP (pre-HD: 8.9 mmHg, p ¼ 0.02; post-HD: 15.3 mmHg, p ¼ 0.0003) and phosphorous levels (0.71 mg/dL, p ¼ 0.02). Although the increase in albumin levels did not reach statistical significance, the increase in nPCR was statistically significant (0.08 g/kg/day, p ¼ 0.02). A sub-analysis was conducted where nine patients with increased prescribed treatment times were removed, in order to assess the change in average eKt/V without the influence of prescribed treatment time changes. These patients had an increase in prescribed treatment time for these reasons: phosphorus control (3), adequacy (3), excess fluid gains (2), and non-adherence (1). In patients without prescribed treatment time increase, average delivered treatment time changed minimally (6.1 minutes), comparing Month 1 and 12. However, there was a statistically significant increase in average eKt/V (0.24, p ¼ 0.02). The difference was similar to the increase seen overall in the hypertensive patients (0.28). Figure 2 shows the average pre- and post-HD SBP for Baseline Hypertensive patients with complete data for each month (n ¼ 25). This allows comparison of monthly means with the same population across time. The highest average pre-HD SBP occurred in Month 1 (163.4 mmHg) and the lowest average pre-HD SBP was in Month 7 (154.2 mmHg). The average post-SBP in Month 1 was 149.7 mmHg, and it reached the lowest level in Month 12 (136.1 mmHg). www.cmrojournal.com ! 2015 Informa UK Ltd
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*Values are presented as the average for all available patients SD from Month 1 to Month 12. nPCR: normalized protein catabolic rate; OLC: online clearance; eKt/V: equilibrated Kt/V; BV: blood volume; HD: hemodialysis; IDWG: interdialytic weight gain; SBP: systolic blood pressure; Phos: phosphorus.
1.5 0.3 1.6 0.3 1.6 0.3 1.6 0.3 1.6 0.2 1.6 0.2 1.6 0.2 1.7 0.3 1.7 0.3 1.7 0.3 1.7 0.2 1.7 0.2 0.21, p50.0001 1.3 0.2 1.5 0.2 1.5 0.3 1.5 0.2 1.4 0.2 1.4 0.3 1.5 0.2 1.6 0.4 1.5 0.2 1.5 0.2 1.8 0.5 1.6 0.2 0.25, p50.0001 6.4 2.1 5.9 1.9 5.8 2.0 5.7 1.9 5.9 2.2 6.3 2.0 5.9 1.9 5.7 1.8 5.9 1.7 5.4 1.5 5.5 1.9 5.7 2.1 0.9, p ¼ 0.001 0.8 0.2 0.9 0.3 0.9 0.3 0.9 0.3 0.9 0.2 0.9 0.2 0.9 0.3 0.9 0.2 0.9 0.3 1.0 0.3 1.0 0.3 1.0 0.3 0.06, p ¼ 0.06 2.4 0.9 2.4 0.8 2.3 0.7 2.4 0.9 2.5 0.8 2.6 0.9 2.5 1.0 2.6 0.9 2.6 0.9 2.7 0.9 2.4 0.8 2.5 0.9 0.02, p ¼ 0.9 83.3 28.7 83.2 28.8 83.4 28.4 83.0 28.0 82.6 28.0 83.2 28.1 83.4 28.2 83.0 26.7 83.2 26.7 81.6 25.6 81.6 25.4 81.9 25.7 0.24, p ¼ 0.7 – 6.8 3.7 7.0 2.9 7.6 2.4 7.7 2.9 7.9 3.1 7.0 2.9 7.1 3.0 6.7 3.0 6.7 3.3 6.5 2.9 7.1 3.3 0.1, p ¼ 0.89 1 2 3 4 5 6 7 8 9 10 11 12 12–0, p value
210 23 211 23 212 23 211 23 211 22 211 22 212 22 218 21 221 23 219 22 219 22 219 22 10.6, p ¼ 0.002
81.0 28.4 80.8 28.4 81.0 28.0 80.6 27.7 80.2 27.8 80.6 27.8 80.9 27.8 80.5 26.3 80.7 26.3 79.0 25.1 79.2 25.0 79.4 25.3 0.32, p ¼ 0.6
149 24 147 23 148 22 144 23 141 24 143 22 145 22 148 24 149 23 152 21 152 19 150 19 4.7, p ¼ 0.13
140 22 138 23 143 22 138 21 135 22 133 22 135 21 135 22 133 20 133 15 132 15 132 16 10.6, p ¼ 0.003
3.9 0.4 3.9 0.4 3.9 0.5 3.9 0.4 4.0 0.4 4.0 0.4 4.0 0.4 4.0 0.3 4.0 0.5 4.1 0.4 4.0 0.4 4.1 0.3 0.07, p ¼ 0.09
eKt/V Phos (mg/dL) nPCR (g/kg/day) IDWG (kg) Post-HD weight (kg) Pre-HD weight (kg) Treatment time (minutes) End of treatment percentage change BV Month*
Table 2. Clinical parameters over time for all patients.
Pre-HD SBP (mmHg)
Post-HD SBP (mmHg)
Albumin (g/dL)
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A mixed effects model was used to estimate the changes per month for all baseline hypertensive patients (n ¼ 28). On average, estimated monthly change was 0.7 mmHg for pre-HD SBP (p ¼ 0.04), 1.9 mmHg for post-HD SBP (p50.0001), 1.5 minutes for treatment time (p ¼ 0.001), 0.02 for eKt/V (p50.0001), and 0.01 for OLC (p ¼ 0.007). There was no statistically significant decrease in pre- or post-HD weights or interdialytic weight gain.
Antihypertensive medication changes in patients with baseline hypertension To determine whether the decreases observed in SBP among baseline hypertensive patients were due to increases in antihypertensive medications, the trajectory of SBP slopes were compared within categories of antihypertensive medication change. Cumulative data through Month 12 are presented in Table 4. The 28 baseline hypertensive patients were categorized into three groups: those that showed a decrease in the average change in SBP (SBP D), those who showed no change in SBP, and those who showed an increase in SBP D. In the Decrease (n ¼ 13), No Change (n ¼ 10), and Increase groups (n ¼ 5), the SBP D was 25.7 20, 1.1 6.4, and 19 8.3 mmHg, respectively. Thirty-one percent of patients in the Decrease group had reduction in their antihypertensive medications (half stopped antihypertensive medications entirely), antihypertensive medications increased in 15%, were unchanged in 15%, and changed without clear increase or decrease in 39%. Overall, antihypertensive medications were reduced for eight patients (29%, 3/8 stopping all antihypertensive medications), increased for three (11%), unchanged for seven (25%), and varied in 10 (36%).
Discussion In this ongoing quality improvement project, BV monitoring was used as a tool to improve overall fluid management in HD patients. Over the 12 month period, a decrease in post-HD SBP and increase in adequacy and treatment time were observed. After stratification by baseline hypertension (pre-HD SBP 140 mmHg), further statistically significant changes were noted. There were significant increases in the average dialysis treatment time (15.4 minutes, p ¼ 0.0005), the average eKt/V (0.28, p ¼ 0.0002), and the average OLC (0.22, p ¼ 0.0001). There were significant decreases in the pre- and post-HD SBP (pre-HD: 8.9 mmHg, p ¼ 0.02; post-HD: 15.3 mmHg, p ¼ 0.0003) and phosphorous levels (0.71 mg/dL, p ¼ 0.02). The lowering of SBP was not associated with increased use of antihypertensive medications. There was a trend toward improvement in nutritional markers with Fluid management in hemodialysis Balter et al.
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40.0%
% of Dialysis Treatments
35.0% 30.0% 25.0% Symptoms∗∗
20.0%
Hypotension
15.0%
Saline∗
10.0%
Ultrafiltration Off/Min
5.0%
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0.0% Month Month Month Month Month Month Month Month 2 3 4 5 6 7 8 9 Quality Improvement Project Month
Figure 1. Distribution of intradialytic morbidity and intervention from Month 2 through Month 9. Values are represented as the average percentage for that month. *Saline administered beyond routine initiation and conclusion of dialysis; excludes saline given for reasons such as, but not limited to, dialysis interruption or prescription of heparin-free dialysis. **Includes any symptom reported including cramping, ‘not feeling well’, light-headedness, and so forth.
a statistically non-significant increase in albumin levels (0.07; p ¼ 0.09) and statistically significant increase in nPCR (0.08 g/kg/day, p ¼ 0.02). Longitudinal data analysis techniques supported these findings. Despite improvements in BP control, adequacy and nutritional markers, no statistically significant differences were observed in the mean monthly percentage change BV, post-HD weight, or IDWG. There was an initial lowering of percentage change BV in the earlier months, but this was not sustained. The duration of this quality improvement project is longer than most published BV monitoring projects and monthly means of percentage change BV may obscure smaller changes within the month. However, Patel and colleagues demonstrated that BV monitoring led to improved post-HD SBP control and reduction in antihypertensive medications, without significant weight change in a pediatric HD population over 6 months, possibly due to gain in ‘true weight’23. In the present study, the lack of persistent and significant lowering of weights could be related to concomitant improvement in patients’ nutritional status. This is supported by observed increases in nPCR and serum albumin values. Other studies have suggested that hypervolemia may contribute to hypoalbuminaria and malnutrition, and elevated nutritional marker levels, such as nPCR and albumin, may result in increased lean body mass24–26. It is worth noting that seasonal effects on factors such as weight may also obscure smaller changes over time27. Antihypertensive medications use was reduced among patients with baseline hypertension, suggesting that 1328
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improved fluid management may be helpful in managing hypertension. Analysis of changes in antihypertensive medication use in baseline hypertensive patients suggests that increases in antihypertensive medications were not causing SBP reduction. Patients who had antihypertensive medications decreased (Decrease group) had the largest drop in SBP, while the patients with an increase in antihypertensive medications (Increase group) experienced a rise in SBP. Additionally, antihypertensive medication use in dialysis patients has been controversial and may not be considered appropriate for all patients6. For instance, antihypertensive medications can interfere with compensatory vasoconstriction that maintains BP during rapid intravascular volume changes28. This may raise the risk of symptomatic intradialytic hypotension during HD. Thus, aiming to reduce antihypertensive medications in HD patients is warranted. In baseline hypertensive patients, significant increases in dialysis treatment time, as well as adequacy and clearance were observed. Increased adequacy could be due to decreases in time when UF was reduced or set to minimum, thus allowing continuous treatment29. The increase in treatment time could contribute to improved clearance, fluid removal, and BP control30. Although the improvements in adequacy remained in the patients without prescribed treatment time increases, this quality improvement project substantiates the importance of longer treatment times. This analysis has some limitations that should be considered. First, this was a single, clinic-wide, quality improvement project with no control group. www.cmrojournal.com ! 2015 Informa UK Ltd
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*p value from paired t-test comparing difference between Months 12 and 1. BV: blood volume; nPCR: normalized protein catabolic rate; OLC: online clearance; eKt/V: equilibrated Kt/V; BV: blood volume; HD: hemodialysis; IDWG: interdialytic weight gain; SBP: systolic blood pressure; Phos: phosphorus.
1.52 0.26 1.62 0.29 1.68 0.26 1.60 0.23 1.55 0.22 1.53 0.23 1.58 0.22 1.66 0.28 1.73 0.29 1.71 0.28 1.70 0.23 1.72 0.22 0.22, p ¼ 0.0001 1.32 0.23 1.50 0.24 1.51 0.28 1.45 0.16 1.42 0.22 1.42 0.33 1.47 0.26 1.65 0.44 1.53 0.20 1.53 0.20 1.83 0.51 1.60 0.20 0.28, p ¼ 0.0002 6.6 2.3 6.2 2.1 6.1 2.2 6.0 1.8 6.1 2.4 6.4 2.2 6.1 2.2 5.9 2.0 6.0 1.9 5.4 1.5 5.9 1.9 6.1 2.3 0.71, p ¼ 0.02 0.88 0.24 0.95 0.26 0.92 0.30 0.98 0.24 0.92 0.23 0.94 0.23 1.00 0.27 0.97 0.24 0.99 0.27 1.03 0.26 1.05 0.29 0.99 0.28 0.08, p ¼ 0.02 3.95 0.42 3.91 0.42 3.97 0.40 3.95 0.42 3.98 0.44 4.01 0.41 4.03 0.39 4.01 0.37 4.04 0.50 4.04 0.41 4.01 0.44 4.07 0.38 0.05, p ¼ 0.27 2.5 0.9 2.5 0.8 2.4 0.7 2.5 0.8 2.5 0.9 2.6 1.0 2.6 1.0 2.7 0.9 2.6 1.0 2.8 0.9 2.5 0.8 2.5 0.7 0.02, p ¼ 0.9 82.7 29.2 82.4 29.0 81.7 28.2 81.4 27.8 81.4 27.3 81.4 27.3 81.6 27.4 82.7 27.4 82.9 27.5 80.5 25.9 80.6 25.6 80.8 25.8 0.45, p ¼ 0.57 208 25 211 25 213 26 211 23 210 23 211 23 211 22 219 20 223 23 221 22 221 21 222 21 15.4, p ¼ 0.0005 1 2 3 4 5 6 7 8 9 10 11 12 12–0, p value*
– 6.6 3.7 7.1 3.0 7.5 2.6 7.6 2.8 7.6 3.2 6.7 3.0 6.8 3.2 6.4 3.4 6.5 3.6 6.4 3.2 6.6 3.4 0.12, p ¼ 0.8
80.3 28.9 79.9 28.6 79.2 27.8 78.8 27.4 78.8 27.0 78.8 26.9 79.0 27.0 80.1 26.9 80.3 27.1 77.8 25.5 78.1 25.3 78.3 25.6 0.52, p ¼ 0.50
164 14 160 14 160 15 156 19 153 18 153 18 153 19 155 20 155 20 158 17 159 15 156 16 8.9, p ¼ 0.02
151 17 150 16 154 19 148 18 144 20 141 21 141 21 140 21 138 19 136 13 137 13 136 15 15.3, p ¼ 0.0003
nPCR (g/kg/day) Albumin (g/dL) Post-HD SBP (mmHg) Pre-HD SBP (mmHg) IDWG (kg) Post-HD weight (kg) Pre-HD weight (kg) Treatment time (minutes) End of treatment percentage change BV Month
Table 3. Clinical parameters over time in baseline hypertensive dialysis patients on fluid management.
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Phos (mg/dL)
eKt/V
OLC
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Second, data were collected under real-world clinic conditions, not as part of a controlled clinical study where only routinely measured clinical variables were available and missing data were possible. Also, the analysis of BV data through monthly averages may have masked changes within the monthly time frame. Finally, quality improvement project analyses were not adjusted for death or the presence of hypotensive-prone or -resistant patients. After initiation of this fluid management quality improvement project using BV monitoring, treatment times increased, dialysis adequacy and possibly nutritive status improved, pre- and post-HD SBP decreased, and the need for antihypertensive medications in baseline hypertensive patients was reduced.
Conclusions In summary, during this 12 month long fluid management ongoing quality improvement project, decreases in postdialysis SBP and increases in adequacy and treatment time were observed. Patients with hypertension at Month 1 experienced reductions in pre-dialysis SBP and antihypertensive medications. Over the 12 month period, a decrease in post-HD SBP and increase in adequacy and treatment time were observed. After stratification by baseline hypertension, significant increases in the average dialysis treatment time, the average eKt/V, and the average OLC were observed. In addition, there were significant decreases in the pre- and post-HD SBP and phosphorous levels. The lowering of SBP was not associated with increased use of antihypertensive medications. Improving fluid management with BV monitoring should continue to be investigated in patients on hemodialysis.
Transparency Declaration of funding This quality improvement initiative is funded by the Renal Research Institute (RRI). Declaration of financial/other relationships P.B. has disclosed that he is the Medical Director of Renal Research Institute, and owns stock in the company. L.H.F. and P.B.T. have disclosed that they are employees of Fresenius Medical Care. L.U., D.A.S., C.M., and P.Z. have disclosed that they are employees of Fresenius Medical Care and own stock in the company. J.D.-B. has disclosed that he is a consultant/advisor to Fresenius Medical Care. Acknowledgments The authors thank RRI clinical staff including Antoinette Ordish RN and Penny Sheppard for their contributions to the data collection.
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170
Post-dialysis SBP (mmHg)
Systolic Blood Pressure (SBP) in mmHg
165
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Pre-dialysis SBP (mmHg)
163.4 160.4
161.5
160
158.4
157.2
156.6 154.3 154.6 154.2
155
160 156.7
155.7
154.8
150 149.7 149.9
148.8
145
144
140
141.3 141.5 141.1
135
137.3 136.5 137.1 136.1
130 125 120 0
1
2
3
4
5
6
7
8
9
10
11
12
13
Month
Figure 2. Monthly changes in pre- and post-HD SBP in Baseline Hypertensive patients. Pre- and post-dialysis SBP in hypertensive groups are shown through Month 12. Values given in mmHg. Monthly average post-dialysis SBP is denoted by the filled diamond and the pre-dialysis SBP by the filled square.
Table 4. Blood pressure medication changes by change in pre-HD SBP in Baseline Hypertensive group. Pre-HD SBP (n ¼ 28)
Decrease (46%) No Change (36%) Increase (18%)
Anti-hypertensive medication changes Reduction 8 (29%)
Increase 3 (11%)
No change 7 (25%)
Variation* 10 (36%)
4 2 2
2 0 1
2 4 1
5 4 1
*Patient had a change in anti-hypertension regimen; however, physician who reviewed the change indicated it was a switch without a clear increase or decrease.
References 1. Hecking M, Karaboyas A, Antlanger M, et al. Significance of interdialytic weight gain versus chronic volume overload: consensus opinion. Am J Nephrol 2013;38:78-90 2. Maduell F, Arias M, Masso´ E, et al. Sensitivity of blood volume monitoring for fluid status assessment in hemodialysis patients. Blood Purif 2013;35: 202-8 3. Wabel P, Moissl U, Chamney P, et al. Towards improved cardiovascular management: the necessity of combining blood pressure and fluid overload. Nephrol Dial Transplant 2008;23:2965-71 4. Saran R, Bragg-Gresham JL, Rayner HC, et al. Nonadherence in hemodialysis: associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int. 2003;64:254-62 5. Kalantar-Zadeh K, Regidor DL, Kovesdy CP, et al. Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis. Circulation 2009;119:671-9 6. Chazot C, Wabel P, Chamney P, et al. Importance of normohydration for the long-term survival of haemodialysis patients. Nephrol Dial Transplant 2012;27:2404-10 7. Wizemann V, Wabel P, Chamney P, et al. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant 2009;24:1574-9
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8. Mailloux LU, Haley WE. Hypertension in the ESRD patient: pathophysiology, therapy, outcomes, and future directions. Am J Kidney Dis 1998;32:705-19 9. Pe´rez-Garcı´a R, Lo´pez-Go´mez JM, Jofre R, et al. Haemodialysis dose, extracellular volume control and arterial hypertension. Nephrol Dial Transplant 2001;16(Suppl 1):98-101 10. Ho¨rl WH. Hypertension in end-stage renal disease: different measures and their prognostic significance. Nephrol Dial Transplant 2010;25:3161-6 11. Peixoto AJ, Santos SF. Blood pressure management in hemodialysis: what have we learned? National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Hemodialysis Adequacy, update 2006. Am J Kidney Dis 2006;48:S33-9 12. Sinha AD. Why assistive technology is needed for probing of dry weight. Blood Purif 2011;31:197-202 13. Hur E, Usta M, Toz H, et al. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis 2013;61: 957-65 14. Choi SH, Shin DS, Jung ES, et al. Prognostic implication of interdialytic fluid retention during the beginning period in incident hemodialysis patients. Tohoku J Exp Med 2012;226:109-15 15. Parker 3rd T, Hakim R, Nissenson AR, et al. Dialysis at a crossroads: 50 years later. CJASN 2011;2:457-61
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16. Lopot F, Kotyk P, Bla´ha J, Forejt J. Use of continuous blood volume monitoring to detect inadequately high dry weight. Int J Artif Organs 1996;19: 411-14 17. Steuer RR, Germain MJ, Leypoldt JK, Cheung AK. Enhanced fluid removal guided by blood volume monitoring during chronic hemodialysis. Artif Organs 1998;22:627-32 18. Agarwal R. Hypervolemia is associated with increased mortality among hemodialysis patients. Hypertension 2010;56:512-17 19. Rodriguez HJ, Domenici R, Diroll A, Goykhman I. Assessment of dry weight by monitoring changes in blood volume during hemodialysis using Crit-Line. Kidney Int 2005;68:854-61 20. Parker 3rd TF, Hakim R, Nissenson AR, et al. A quality initiative. Reducing rates of hospitalizations by objectively monitoring volume removal. Nephrol News Issues 2013;27:30-2,34-6 21. Reddan DN, Szczech LA, Hasselblad V, et al. Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial. J Am Soc Nephrol 2005;16:2162-9 22. KDOQI Clinical Practice Guidelines for Cardiovascular Disease in Dialysis Patients. Available at: http://www.kidney.org/professionals/kdoqi/guidelines_ cvd/intradialytic.htm [Last accessed 14 January 2014]
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23. Patel HP, Goldstein SL, Mahan JD, et al. A standard, noninvasive monitoring of hematocrit algorithm improves blood pressure control in pediatric hemodialysis patients. Clin J Am Soc Nephrol 2007;2:252-7 24. Kursat S, Colak HB, Toraman A, et al. The relationship between depression– malnutrition and echocardiographic–blood pressure parameters in chronic hemodialysis patients. Int Urol Nephrol 2008;40:793-9 25. Jones CH, Akbani H, Croft DC, Worth DP. The relationship between serum albumin and hydration status in hemodialysis patients. J Ren Nutr 2002; 12:209-12 26. Dumler F. Hypoalbuminemia is a marker of overhydration in chronic maintenance patients on dialysis. ASAIO J 2003;49:282-6 27. Usvyat LA, Carter M, Thijssen S, et al. Seasonal variations in mortality, clinical, and laboratory parameters in hemodialysis patients: a 5-year cohort study. Clin J Am Soc Nephrol 2012;7:108-15 28. Tomson CR. Blood pressure and outcome in patients on dialysis. Lancet 2009;21;373:981-2 29. Winkler RE, Pa¨tow W, Ahrenholz P. Blood volume monitoring. Contrib Nephrol 2008;161:119-24 30. Daugirdas JT. Dialysis time, survival, and dose-targeting bias. Kidney Int 2013;83:9-13
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ISSN: 0300-7995 (Print) 1473-4877 (Online) Journal homepage: http://www.tandfonline.com/loi/icmo20
A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis Paul Balter, Linda H. Ficociello, Patrice B. Taylor, Len Usvyat, Dixie-Ann Sawin, Claudy Mullon, Jose Diaz-Buxo & Paul Zabetakis To cite this article: Paul Balter, Linda H. Ficociello, Patrice B. Taylor, Len Usvyat, Dixie-Ann Sawin, Claudy Mullon, Jose Diaz-Buxo & Paul Zabetakis (2015) A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis, Current Medical Research and Opinion, 31:7, 1323-1331, DOI: 10.1185/03007995.2015.1047746 To link to this article: http://dx.doi.org/10.1185/03007995.2015.1047746
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Brief report A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis
Paul Balter
Abstract
Renal Research Institute, New York, NY, USA
Linda H. Ficociello Fresenius Medical Care North America, Waltham, MA, USA
Patrice B. Taylor Len Usvyat Renal Research Institute, New York, NY, USA Fresenius Medical Care North America, Waltham, MA, USA
Dixie-Ann Sawin Claudy Mullon Jose Diaz-Buxo Fresenius Medical Care North America, Waltham, MA, USA
Paul Zabetakis Renal Research Institute, New York, NY, USA Address for correspondence: Paul Balter MD, Corporate Medical Director, Renal Research Institute, 120 West 22nd Street, Oak Brook, IL 60523, USA. Tel: +1 630 974 5254; [email protected] Keywords: Clinical nephrology – Fluid management – Hypertension – Monitoring – Quality improvement – Volume control Accepted: 27 April 2015; published online: 2 June 2015 Citation: Curr Med Res Opin 2015; 31:1323–31
Background: Inadequate removal of extracellular volume markedly increases blood pressure and contributes to high morbidity and mortality in hemodialysis patients. Advances in fluid management are needed to improve clinical outcomes. The aim of this quality improvement project was to examine the advantages of using a hematocrit-based, blood volume monitor (Crit-Line*) for 12 months, as part of a clinic-wide, fluid management program in one dialysis facility. Methods: Forty-five individuals were receiving hemodialysis at one facility at project initiation and are included in this analysis. Monthly averaged clinical parameters (dialysis treatment information, blood pressures, blood volume, and laboratory data) were compared from Months 1–12. Analyses were conducted overall and according to the presence/absence of hypertension at Month 1 (Baseline). Antihypertensive medication changes were assessed for patients with hypertension at Month 1. Results: Average hemodialysis treatment time (þ10.6 minutes, p ¼ 0.002), eKt/V (þ0.25, p50.001) and online clearance (þ0.21, p50.0001) increased significantly in Month 12 versus Month 1. Average albumin levels and normalized protein catabolic rate increased from Month 1 to 12. Post-dialysis systolic blood pressure (SBP) decreased by Month 12 (p ¼ 0.003). In hypertensive patients (SBP 140 mmHg in Month 1), there were significant differences in pre- and post-dialysis SBP between Month 1 and Month 12 (prehemodialysis: p ¼ 0.02; post-hemodialysis: p ¼ 0.0003), and antihypertensive medication use decreased in 29% of patients, while only 11% increased use. Treatment time in hypertensive patients increased by 15.4 minutes (p ¼ 0.0005). Limitations: This was a single, clinic-wide, quality improvement project with no control group. All data analyzed were from existing clinical records, so only routinely measured clinical variables were available and missing data were possible. Conclusions: During this year-long fluid management quality improvement project, decreases in post-dialysis SBP and increases in adequacy and treatment time were observed. Patients with hypertension at Month 1 experienced reductions in pre-dialysis SBP and antihypertensive medications.
*Crit-Line is a trademark of Fresenius Medical Care Holdings, Inc. or its affiliated companies.
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Introduction
Design, setting, and duration
Volume or fluid overload is a major problem in chronic hemodialysis (HD) patients, and studies have linked volume overload to increased morbidity and mortality1. Fluid volumes 415% of the extracellular volume (ECV) (i.e., 2.5 L of excess fluid), occur in 25–28% of all HD patients2,3. Several large follow-up studies demonstrated that overhydrated HD patients have increased mortality risk compared with normohydrated HD patients4–7. ECV expansion with subsequent fluid overload may be the most important contributor to hypertension in HD patients8. At the start of dialysis, 80–90% of end-stage renal disease patients are hypertensive and have increased risk of cardiovascular disease9,10. To assist with blood pressure (BP) control, many HD patients are prescribed antihypertensive medications5. Although this approach may have beneficial antihypertensive effects, these medications can affect compensatory vasoconstriction processes, and patients might remain fluid overloaded. Thus, volume control should be an integral component of BP management and achievement of normovolemia – a key target of therapy5,11. Improvements in fluid management have the potential to positively impact clinical outcomes in HD patients12–15. Assistive technologies, including blood volume (BV) monitoring, have been employed to examine and track fluid status changes. These technologies may encourage greater focus on improving excess volume removal and fluid management12. Previous studies indicate that BV monitoring during HD could be used to assess appropriateness of target weight16–18. Some studies examined BV monitoring in clinical settings, but results have been inconsistent19–21. This report describes clinical parameter changes over 12 months of a quality improvement project on fluid management using BV monitoring as part of the daily clinic routine at one dialysis facility.
This report examines the first 12 months (April [Month 1] through March [Month 12]) of a clinic-wide fluid management quality improvement project in one Southeastern United States dialysis facility. All patients receiving dialysis at this facility were eligible for the quality improvement project. This report is limited to the patients in the facility at the quality improvement project start (n ¼ 45), allowing the establishment of baseline in Month 1 before BV monitors were installed.
Methods BV monitor used in this quality improvement project The BV monitor (Crit-Line*) used is a hematocrit (HCT) based BV monitor that is 510 k cleared to non-invasively and continuously measure percentage change in BV, HCT, oxygen saturation, and calculate hemoglobin based on HCT.
*Crit-Line is a trademark of Fresenius Medical Care Holdings, Inc. or its affiliated companies.
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Fluid management initiatives One BV monitor was installed on every HD chair during the first week of Month 2. To allow for staff training and acclimation, interventions began 1 week later for every HD treatment. Concurrent with standard of care that includes assessment of patients’ vital signs and safety parameters every 30 minutes (e.g., BP, pulse, blood flow rate, dialysis flow rate, vascular access check, signs and symptoms), staff were instructed to record percentage change in BV and HCT. At the discretion of the physician, the nurse was allowed to adjust the ultrafiltration (UF) goal up to 200 ml every 30 minutes to obtain a gradual decrease in percentage change BV, as indicated on the BV monitor. To assess whether vascular compartment refill was present at the end of HD, the UF was turned off during the last 15 minutes of the HD session. If there was a decrease in HCT of 0.5 during those 15 minutes, then the patient’s target weight could be adjusted for the next treatment. If a patient became symptomatic or hypotensive, standard clinic procedures were followed including: reducing UF goal, reducing UF to minimum for 10–15 minutes, lowering dialysate temperature from the standard of 37 to 35.5 C, repositioning patient, or administering saline. Oxygen therapy was administered if oxygen saturation fell below 90% for fistula or grafts, or below 60% for catheters. If a patient had large interdialytic fluid gains that could not be removed during the treatment, treatment length could be extended or an extra treatment scheduled. Patients were dialyzed with a 137 mmol/L dialysate sodium, unless a lower sodium concentration was ordered. Ultrafiltration profiles and sodium modeling were not used. Finally, nurses and dieticians stressed the importance of fluid and sodium restriction to the patients.
Clinical and treatment parameters The following data were routinely available from an electronic data warehouse: pre- and post-HD body weight, interdialytic weight gain (IDWG), systolic blood pressure (SBP) and diastolic blood pressure (DBP), pre-HD serum phosphorus, albumin, and normalized protein catabolic rate (nPCR); as well as information on treatment time www.cmrojournal.com ! 2015 Informa UK Ltd
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and adequacy (total eKt/V and on-line clearance [OLC]). The monthly averages for continuous variables were calculated per person. Data on antihypertensive medications were collected quarterly from patient self-reports, bottle checks, and discharge summaries by a nurse. Data recorded on the treatment sheets regarding intradialytic BP changes, symptoms, and interventions made by staff (e.g., saline administration) were reviewed for one week each month from Month 2 (first week of Month 2 after BV monitor installed, but before interventions began) to Month 9 of the project by a nurse. Symptoms during dialysis included all patient-reported discomfort such as cramps, nausea, headache, and general malaise (e.g. ‘not feeling well’). Administration of extra saline (excluding saline needed to start/end HD treatment and any flushes due to clotting or heparin-free treatments) and instances when the UF was set to off/minimum (excluding refill checks) were also recorded. For the current analysis, hypotension was defined according to the National Kidney Foundation Kidney Disease Outcome Quality Initiative (NKF KDOQI) Guidelines22 as a drop of 20 mmHg in SBP or a drop of 10 mmHg in mean arterial pressure (MAP) associated with symptoms. Symptom and SBP drop were not required to occur simultaneously, only within the same dialysis session. BV monitor data including percentage change in BV were captured electronically. Treatments with obvious errors that would impact the ending percentage change in BV were removed including: improbably low starting HCT, short duration, and technical errors (e.g., sensor clip removal/shift). Hospital admissions data were collected and these ICD-9 codes were considered possibly fluid related: 276.6, 276.69, 398.91, 402.01, 402.11, 402.91, 404.03, 404.11, 404.91, 428.0, 428.2, 428.21, 428.22, 428.23, 428.3, 428.31, 428.32, 428.33, 428.4, 428.41, 428.42, 428.43, 514, 518.4, 782.3, 786.05, 1075, 34736. Person-time for calculation of hospital rates was summed over all patients using (last HD date - first HD date)/365. Fluid-related hospital admission rates are reported cumulatively over 12 months, not monthly, due to small sample size and infrequent occurrence.
Analyses and statistical methods Descriptive analyses were performed on data from all 45 patients. Paired t-tests were used to compare clinical outcomes in Month 1 to Month 12 for patients with complete data during those months (n ¼ 36). To account for repeated observations over time on the same patients and utilize incomplete follow-up information, mixed effects linear regression modeling was used to estimate the change per month (n ¼ 45). Patients were stratified according to the presence (SBP 140 mmHg) or absence (SBP5140 mmHg) of hypertension at Month 1. To assess ! 2015 Informa UK Ltd www.cmrojournal.com
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the relation between antihypertensive medication changes and BP changes among hypertensive patients, SBP slopes across categories of medication changes were constructed and analyzed. SBP changes were assessed based on the statistical significance of SBP slope using linear regression.
Results Patient participation and demographics Forty-five patients were included in the current analysis. Thirty-six patients were observed through Month 12; three patients transferred dialysis facility, one patient moved to hospice, and five patients died. Death certificates and discharge summaries, where appropriate, were reviewed for deceased patients. Causes of death for these patients were (1) cancer, (2) chronic obstructive pulmonary disease with multiple co-morbidities, (3) pneumonia, and (4, 5) sudden death arrhythmia. There were 11 possible fluid-related hospitalizations over the year (0.28 per patient-year). Patient demographics are shown in Table 1. On average, patients were aged 59 years with dialysis vintage of 3.6 years. Fifty-six percent of the participants were male, 53% were Black or African American, and 27% were Hispanic. At the start of the project, 80% had a fistula or graft as their vascular access. The average serum sodium level was 138.8 mmol/L, and the standard dialysate sodium concentration was 137 mmol/L.
Changes in clinical parameters (all patients) Table 2 describes the monthly changes in clinical parameters for all patients. Comparisons were made between Months 1 and 12 using t-tests for the patients with data available for both months. There were significant changes in the average treatment time (þ10.6 minutes, p ¼ 0.002), post-HD SBP (-10.6 mmHg, p ¼ 0.003), eKt/V (þ0.25, p50.0001) and OLC (þ0.21, p50.0001) between Month 1 and Month 12. The average albumin levels and nPCR showed increasing trends, with average changes of 0.07 (p ¼ 0.09) and 0.06 (p ¼ 0.06), respectively. There was a trend toward serum phosphorus decreases (0.9 mg/dL, p ¼ 0.001). There was minimal overall change in percentage BV change (0.1%, p ¼ 0.89), post-HD weight (0.32 kg, p ¼ 0.6), and IDWG (0.02 kg, p ¼ 0.9). A mixed effects model was used to estimate changes per month for the complete sample (n ¼ 45). On average, estimated monthly change was 0.5 mmHg for pre-HD SBP (p ¼ 0.09), 1.4 mmHg for post-HD SBP (p50.0001), 1 minute for treatment time (p ¼ 0.002), 0.02 for eKt/V (p50.0001), and 0.01 for OLC (p ¼ 0.002). There was no statistically significant trend toward decreasing preand post-HD weights or IDWG. The monthly mean Fluid management in hemodialysis Balter et al.
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Table 1. Patient demographics and treatment parameters at baseline.
Male (%) Black or African American (%) Hispanic (%) Age (years) Dialysis Vintage (years) % with Fistula or Graft Serum Sodium (mmol/L) Dialysate Sodium (mmol/L)
All patients (n ¼ 45)
Patients with hypertension at baseline (n ¼ 28)*
Patients with normotension at baseline (n ¼ 17)**
56 53 27 59 17 3.6 3.3 80 138.8 2.7 137 0
68 54 32 58 18 3.2 2.8 86 138.6 2.8 137 0
35 53 18 60 16 4.3 4.1 71 139.2 2.5 137 0
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*Pre-dialysis SBP 140 mmHg during Month 1. **Pre-dialysis SBP 5140 mmHg during Month 1.
percentage BV changes ranged from 6.5 2.9% to 7.9 3.1% at treatment end and patients lost an average of 2.2–2.7 kg per treatment.
Intradialytic morbidity and interventions In total, 936 treatment sheets from all available treatments from one week each month were reviewed for Months 2–9. For Month 2, the week during the BV monitor acclimation period (when treatment changes were not made based on percentage change BV) was chosen, serving as the baseline. Figure 1 shows the distribution of intradialytic events and intervention recorded Months 1–8. Intradialytic hypotension and symptoms such as cramping, general malaise, or any other documented patient discomfort were variable across months and throughout the quality improvement project. The percentage of treatments for which saline was administered beyond routine dialysis initiation and discontinuation decreased compared to Month 2 (16.9%) in Months 3, 4, 5, and 9, while there was an increase in Months 6, 7, and 8. The percentage of treatments during which clinic staff turned the UF to minimum or off (not including refill checks) was the highest during Month 2 (36.9%) and lowest for Month 7 (9.6%). Thirtyseven patients (82%) experienced at least one hypotensive episode during the year.
Stratification by baseline hypertension Patients were stratified into two groups for this current report based on mean pre-HD SBP during Month 1. Twenty-eight patients had a mean SBP 140 mmHg (‘Baseline Hypertensive’) and 17 patients had a mean SBP5140 mmHg (‘Baseline Normotensive’) during Month 1. Except for differences in phosphorous levels, the Baseline Normotensive group did not show significant differences in any clinical parameters recorded (Supplemental data). In these patients, serum phosphorus levels decreased from 6.0 1.8 mg/dL in Month 1 to 1326
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4.7 1.1 mg/dL in Month 12 (p ¼ 0.01). In 10 of the 12 months, phosphorus levels were within the KDOQI recommended range of 3.5–5.5 mg/dL (1.13 and 1.78 mmol/L). Table 3 describes monthly changes in clinical parameters in the Baseline Hypertensive group. Comparisons were made between Month 1 and Month 12 using t-tests for the Baseline Hypertensive patients with data from both months. There were significant increases in the average dialysis treatment time (15.4 minutes, p ¼ 0.0005), the average eKt/V (0.28, p ¼ 0.0002), and average OLC (0.22, p ¼ 0.0001). There were significant decreases in the pre- and post-HD SBP (pre-HD: 8.9 mmHg, p ¼ 0.02; post-HD: 15.3 mmHg, p ¼ 0.0003) and phosphorous levels (0.71 mg/dL, p ¼ 0.02). Although the increase in albumin levels did not reach statistical significance, the increase in nPCR was statistically significant (0.08 g/kg/day, p ¼ 0.02). A sub-analysis was conducted where nine patients with increased prescribed treatment times were removed, in order to assess the change in average eKt/V without the influence of prescribed treatment time changes. These patients had an increase in prescribed treatment time for these reasons: phosphorus control (3), adequacy (3), excess fluid gains (2), and non-adherence (1). In patients without prescribed treatment time increase, average delivered treatment time changed minimally (6.1 minutes), comparing Month 1 and 12. However, there was a statistically significant increase in average eKt/V (0.24, p ¼ 0.02). The difference was similar to the increase seen overall in the hypertensive patients (0.28). Figure 2 shows the average pre- and post-HD SBP for Baseline Hypertensive patients with complete data for each month (n ¼ 25). This allows comparison of monthly means with the same population across time. The highest average pre-HD SBP occurred in Month 1 (163.4 mmHg) and the lowest average pre-HD SBP was in Month 7 (154.2 mmHg). The average post-SBP in Month 1 was 149.7 mmHg, and it reached the lowest level in Month 12 (136.1 mmHg). www.cmrojournal.com ! 2015 Informa UK Ltd
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*Values are presented as the average for all available patients SD from Month 1 to Month 12. nPCR: normalized protein catabolic rate; OLC: online clearance; eKt/V: equilibrated Kt/V; BV: blood volume; HD: hemodialysis; IDWG: interdialytic weight gain; SBP: systolic blood pressure; Phos: phosphorus.
1.5 0.3 1.6 0.3 1.6 0.3 1.6 0.3 1.6 0.2 1.6 0.2 1.6 0.2 1.7 0.3 1.7 0.3 1.7 0.3 1.7 0.2 1.7 0.2 0.21, p50.0001 1.3 0.2 1.5 0.2 1.5 0.3 1.5 0.2 1.4 0.2 1.4 0.3 1.5 0.2 1.6 0.4 1.5 0.2 1.5 0.2 1.8 0.5 1.6 0.2 0.25, p50.0001 6.4 2.1 5.9 1.9 5.8 2.0 5.7 1.9 5.9 2.2 6.3 2.0 5.9 1.9 5.7 1.8 5.9 1.7 5.4 1.5 5.5 1.9 5.7 2.1 0.9, p ¼ 0.001 0.8 0.2 0.9 0.3 0.9 0.3 0.9 0.3 0.9 0.2 0.9 0.2 0.9 0.3 0.9 0.2 0.9 0.3 1.0 0.3 1.0 0.3 1.0 0.3 0.06, p ¼ 0.06 2.4 0.9 2.4 0.8 2.3 0.7 2.4 0.9 2.5 0.8 2.6 0.9 2.5 1.0 2.6 0.9 2.6 0.9 2.7 0.9 2.4 0.8 2.5 0.9 0.02, p ¼ 0.9 83.3 28.7 83.2 28.8 83.4 28.4 83.0 28.0 82.6 28.0 83.2 28.1 83.4 28.2 83.0 26.7 83.2 26.7 81.6 25.6 81.6 25.4 81.9 25.7 0.24, p ¼ 0.7 – 6.8 3.7 7.0 2.9 7.6 2.4 7.7 2.9 7.9 3.1 7.0 2.9 7.1 3.0 6.7 3.0 6.7 3.3 6.5 2.9 7.1 3.3 0.1, p ¼ 0.89 1 2 3 4 5 6 7 8 9 10 11 12 12–0, p value
210 23 211 23 212 23 211 23 211 22 211 22 212 22 218 21 221 23 219 22 219 22 219 22 10.6, p ¼ 0.002
81.0 28.4 80.8 28.4 81.0 28.0 80.6 27.7 80.2 27.8 80.6 27.8 80.9 27.8 80.5 26.3 80.7 26.3 79.0 25.1 79.2 25.0 79.4 25.3 0.32, p ¼ 0.6
149 24 147 23 148 22 144 23 141 24 143 22 145 22 148 24 149 23 152 21 152 19 150 19 4.7, p ¼ 0.13
140 22 138 23 143 22 138 21 135 22 133 22 135 21 135 22 133 20 133 15 132 15 132 16 10.6, p ¼ 0.003
3.9 0.4 3.9 0.4 3.9 0.5 3.9 0.4 4.0 0.4 4.0 0.4 4.0 0.4 4.0 0.3 4.0 0.5 4.1 0.4 4.0 0.4 4.1 0.3 0.07, p ¼ 0.09
eKt/V Phos (mg/dL) nPCR (g/kg/day) IDWG (kg) Post-HD weight (kg) Pre-HD weight (kg) Treatment time (minutes) End of treatment percentage change BV Month*
Table 2. Clinical parameters over time for all patients.
Pre-HD SBP (mmHg)
Post-HD SBP (mmHg)
Albumin (g/dL)
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A mixed effects model was used to estimate the changes per month for all baseline hypertensive patients (n ¼ 28). On average, estimated monthly change was 0.7 mmHg for pre-HD SBP (p ¼ 0.04), 1.9 mmHg for post-HD SBP (p50.0001), 1.5 minutes for treatment time (p ¼ 0.001), 0.02 for eKt/V (p50.0001), and 0.01 for OLC (p ¼ 0.007). There was no statistically significant decrease in pre- or post-HD weights or interdialytic weight gain.
Antihypertensive medication changes in patients with baseline hypertension To determine whether the decreases observed in SBP among baseline hypertensive patients were due to increases in antihypertensive medications, the trajectory of SBP slopes were compared within categories of antihypertensive medication change. Cumulative data through Month 12 are presented in Table 4. The 28 baseline hypertensive patients were categorized into three groups: those that showed a decrease in the average change in SBP (SBP D), those who showed no change in SBP, and those who showed an increase in SBP D. In the Decrease (n ¼ 13), No Change (n ¼ 10), and Increase groups (n ¼ 5), the SBP D was 25.7 20, 1.1 6.4, and 19 8.3 mmHg, respectively. Thirty-one percent of patients in the Decrease group had reduction in their antihypertensive medications (half stopped antihypertensive medications entirely), antihypertensive medications increased in 15%, were unchanged in 15%, and changed without clear increase or decrease in 39%. Overall, antihypertensive medications were reduced for eight patients (29%, 3/8 stopping all antihypertensive medications), increased for three (11%), unchanged for seven (25%), and varied in 10 (36%).
Discussion In this ongoing quality improvement project, BV monitoring was used as a tool to improve overall fluid management in HD patients. Over the 12 month period, a decrease in post-HD SBP and increase in adequacy and treatment time were observed. After stratification by baseline hypertension (pre-HD SBP 140 mmHg), further statistically significant changes were noted. There were significant increases in the average dialysis treatment time (15.4 minutes, p ¼ 0.0005), the average eKt/V (0.28, p ¼ 0.0002), and the average OLC (0.22, p ¼ 0.0001). There were significant decreases in the pre- and post-HD SBP (pre-HD: 8.9 mmHg, p ¼ 0.02; post-HD: 15.3 mmHg, p ¼ 0.0003) and phosphorous levels (0.71 mg/dL, p ¼ 0.02). The lowering of SBP was not associated with increased use of antihypertensive medications. There was a trend toward improvement in nutritional markers with Fluid management in hemodialysis Balter et al.
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40.0%
% of Dialysis Treatments
35.0% 30.0% 25.0% Symptoms∗∗
20.0%
Hypotension
15.0%
Saline∗
10.0%
Ultrafiltration Off/Min
5.0%
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0.0% Month Month Month Month Month Month Month Month 2 3 4 5 6 7 8 9 Quality Improvement Project Month
Figure 1. Distribution of intradialytic morbidity and intervention from Month 2 through Month 9. Values are represented as the average percentage for that month. *Saline administered beyond routine initiation and conclusion of dialysis; excludes saline given for reasons such as, but not limited to, dialysis interruption or prescription of heparin-free dialysis. **Includes any symptom reported including cramping, ‘not feeling well’, light-headedness, and so forth.
a statistically non-significant increase in albumin levels (0.07; p ¼ 0.09) and statistically significant increase in nPCR (0.08 g/kg/day, p ¼ 0.02). Longitudinal data analysis techniques supported these findings. Despite improvements in BP control, adequacy and nutritional markers, no statistically significant differences were observed in the mean monthly percentage change BV, post-HD weight, or IDWG. There was an initial lowering of percentage change BV in the earlier months, but this was not sustained. The duration of this quality improvement project is longer than most published BV monitoring projects and monthly means of percentage change BV may obscure smaller changes within the month. However, Patel and colleagues demonstrated that BV monitoring led to improved post-HD SBP control and reduction in antihypertensive medications, without significant weight change in a pediatric HD population over 6 months, possibly due to gain in ‘true weight’23. In the present study, the lack of persistent and significant lowering of weights could be related to concomitant improvement in patients’ nutritional status. This is supported by observed increases in nPCR and serum albumin values. Other studies have suggested that hypervolemia may contribute to hypoalbuminaria and malnutrition, and elevated nutritional marker levels, such as nPCR and albumin, may result in increased lean body mass24–26. It is worth noting that seasonal effects on factors such as weight may also obscure smaller changes over time27. Antihypertensive medications use was reduced among patients with baseline hypertension, suggesting that 1328
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improved fluid management may be helpful in managing hypertension. Analysis of changes in antihypertensive medication use in baseline hypertensive patients suggests that increases in antihypertensive medications were not causing SBP reduction. Patients who had antihypertensive medications decreased (Decrease group) had the largest drop in SBP, while the patients with an increase in antihypertensive medications (Increase group) experienced a rise in SBP. Additionally, antihypertensive medication use in dialysis patients has been controversial and may not be considered appropriate for all patients6. For instance, antihypertensive medications can interfere with compensatory vasoconstriction that maintains BP during rapid intravascular volume changes28. This may raise the risk of symptomatic intradialytic hypotension during HD. Thus, aiming to reduce antihypertensive medications in HD patients is warranted. In baseline hypertensive patients, significant increases in dialysis treatment time, as well as adequacy and clearance were observed. Increased adequacy could be due to decreases in time when UF was reduced or set to minimum, thus allowing continuous treatment29. The increase in treatment time could contribute to improved clearance, fluid removal, and BP control30. Although the improvements in adequacy remained in the patients without prescribed treatment time increases, this quality improvement project substantiates the importance of longer treatment times. This analysis has some limitations that should be considered. First, this was a single, clinic-wide, quality improvement project with no control group. www.cmrojournal.com ! 2015 Informa UK Ltd
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*p value from paired t-test comparing difference between Months 12 and 1. BV: blood volume; nPCR: normalized protein catabolic rate; OLC: online clearance; eKt/V: equilibrated Kt/V; BV: blood volume; HD: hemodialysis; IDWG: interdialytic weight gain; SBP: systolic blood pressure; Phos: phosphorus.
1.52 0.26 1.62 0.29 1.68 0.26 1.60 0.23 1.55 0.22 1.53 0.23 1.58 0.22 1.66 0.28 1.73 0.29 1.71 0.28 1.70 0.23 1.72 0.22 0.22, p ¼ 0.0001 1.32 0.23 1.50 0.24 1.51 0.28 1.45 0.16 1.42 0.22 1.42 0.33 1.47 0.26 1.65 0.44 1.53 0.20 1.53 0.20 1.83 0.51 1.60 0.20 0.28, p ¼ 0.0002 6.6 2.3 6.2 2.1 6.1 2.2 6.0 1.8 6.1 2.4 6.4 2.2 6.1 2.2 5.9 2.0 6.0 1.9 5.4 1.5 5.9 1.9 6.1 2.3 0.71, p ¼ 0.02 0.88 0.24 0.95 0.26 0.92 0.30 0.98 0.24 0.92 0.23 0.94 0.23 1.00 0.27 0.97 0.24 0.99 0.27 1.03 0.26 1.05 0.29 0.99 0.28 0.08, p ¼ 0.02 3.95 0.42 3.91 0.42 3.97 0.40 3.95 0.42 3.98 0.44 4.01 0.41 4.03 0.39 4.01 0.37 4.04 0.50 4.04 0.41 4.01 0.44 4.07 0.38 0.05, p ¼ 0.27 2.5 0.9 2.5 0.8 2.4 0.7 2.5 0.8 2.5 0.9 2.6 1.0 2.6 1.0 2.7 0.9 2.6 1.0 2.8 0.9 2.5 0.8 2.5 0.7 0.02, p ¼ 0.9 82.7 29.2 82.4 29.0 81.7 28.2 81.4 27.8 81.4 27.3 81.4 27.3 81.6 27.4 82.7 27.4 82.9 27.5 80.5 25.9 80.6 25.6 80.8 25.8 0.45, p ¼ 0.57 208 25 211 25 213 26 211 23 210 23 211 23 211 22 219 20 223 23 221 22 221 21 222 21 15.4, p ¼ 0.0005 1 2 3 4 5 6 7 8 9 10 11 12 12–0, p value*
– 6.6 3.7 7.1 3.0 7.5 2.6 7.6 2.8 7.6 3.2 6.7 3.0 6.8 3.2 6.4 3.4 6.5 3.6 6.4 3.2 6.6 3.4 0.12, p ¼ 0.8
80.3 28.9 79.9 28.6 79.2 27.8 78.8 27.4 78.8 27.0 78.8 26.9 79.0 27.0 80.1 26.9 80.3 27.1 77.8 25.5 78.1 25.3 78.3 25.6 0.52, p ¼ 0.50
164 14 160 14 160 15 156 19 153 18 153 18 153 19 155 20 155 20 158 17 159 15 156 16 8.9, p ¼ 0.02
151 17 150 16 154 19 148 18 144 20 141 21 141 21 140 21 138 19 136 13 137 13 136 15 15.3, p ¼ 0.0003
nPCR (g/kg/day) Albumin (g/dL) Post-HD SBP (mmHg) Pre-HD SBP (mmHg) IDWG (kg) Post-HD weight (kg) Pre-HD weight (kg) Treatment time (minutes) End of treatment percentage change BV Month
Table 3. Clinical parameters over time in baseline hypertensive dialysis patients on fluid management.
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Phos (mg/dL)
eKt/V
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Second, data were collected under real-world clinic conditions, not as part of a controlled clinical study where only routinely measured clinical variables were available and missing data were possible. Also, the analysis of BV data through monthly averages may have masked changes within the monthly time frame. Finally, quality improvement project analyses were not adjusted for death or the presence of hypotensive-prone or -resistant patients. After initiation of this fluid management quality improvement project using BV monitoring, treatment times increased, dialysis adequacy and possibly nutritive status improved, pre- and post-HD SBP decreased, and the need for antihypertensive medications in baseline hypertensive patients was reduced.
Conclusions In summary, during this 12 month long fluid management ongoing quality improvement project, decreases in postdialysis SBP and increases in adequacy and treatment time were observed. Patients with hypertension at Month 1 experienced reductions in pre-dialysis SBP and antihypertensive medications. Over the 12 month period, a decrease in post-HD SBP and increase in adequacy and treatment time were observed. After stratification by baseline hypertension, significant increases in the average dialysis treatment time, the average eKt/V, and the average OLC were observed. In addition, there were significant decreases in the pre- and post-HD SBP and phosphorous levels. The lowering of SBP was not associated with increased use of antihypertensive medications. Improving fluid management with BV monitoring should continue to be investigated in patients on hemodialysis.
Transparency Declaration of funding This quality improvement initiative is funded by the Renal Research Institute (RRI). Declaration of financial/other relationships P.B. has disclosed that he is the Medical Director of Renal Research Institute, and owns stock in the company. L.H.F. and P.B.T. have disclosed that they are employees of Fresenius Medical Care. L.U., D.A.S., C.M., and P.Z. have disclosed that they are employees of Fresenius Medical Care and own stock in the company. J.D.-B. has disclosed that he is a consultant/advisor to Fresenius Medical Care. Acknowledgments The authors thank RRI clinical staff including Antoinette Ordish RN and Penny Sheppard for their contributions to the data collection.
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170
Post-dialysis SBP (mmHg)
Systolic Blood Pressure (SBP) in mmHg
165
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Pre-dialysis SBP (mmHg)
163.4 160.4
161.5
160
158.4
157.2
156.6 154.3 154.6 154.2
155
160 156.7
155.7
154.8
150 149.7 149.9
148.8
145
144
140
141.3 141.5 141.1
135
137.3 136.5 137.1 136.1
130 125 120 0
1
2
3
4
5
6
7
8
9
10
11
12
13
Month
Figure 2. Monthly changes in pre- and post-HD SBP in Baseline Hypertensive patients. Pre- and post-dialysis SBP in hypertensive groups are shown through Month 12. Values given in mmHg. Monthly average post-dialysis SBP is denoted by the filled diamond and the pre-dialysis SBP by the filled square.
Table 4. Blood pressure medication changes by change in pre-HD SBP in Baseline Hypertensive group. Pre-HD SBP (n ¼ 28)
Decrease (46%) No Change (36%) Increase (18%)
Anti-hypertensive medication changes Reduction 8 (29%)
Increase 3 (11%)
No change 7 (25%)
Variation* 10 (36%)
4 2 2
2 0 1
2 4 1
5 4 1
*Patient had a change in anti-hypertension regimen; however, physician who reviewed the change indicated it was a switch without a clear increase or decrease.
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