JOURNAL OF DIALYSIS, 3 ( 2 & 3 ) , 173-190 (1979)
RELATIVE PERFORMANCE TEST OF HOLLOW FIBER DIALYZERS
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H. Naito, M. Shimizu, M. IIigashi Konan Hospital, Central Renal Unit 1-6-7 Kamokogahara, Sumiyoshi, Higashinada-ku, Kobe, Japan
ABSTRACT While a number of different hollow fiber dialyzers are on the market today, the present author studied three of the cellulosic membrane dialyzers, SD-1, CF-1500 and K-102, as to their dialysance, solutes removal rate, UFR and blood residue characteristics. In order to compare these characteristics due to the difference of the membrane and the structural geometry of the dialyzers, the test results were analysed by means of analyses of variance.
INTRODUCTION While a variety of hollow fiber dialyzers are available on the market nowadays, many of them incorporate cellulosic membranes. Although PMMA (polymethyl methacrylate), EVA (ethylenevinyl alcohol) and PAN (polyacrylonitrile) membranes have recently been introduced, these membranes are so high in permeability to water as compared with that to solutes that when such membranes are used in hernodialysis applications, the rate of ultrafiltration 173 Copyright 0 1979 hy Marcel Dekker, Inc. All Rights Reserved. Neither this work nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical. including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher.
174
NAITO, SHIMIZU, AND HIGASHI
cannot b e e a s i l y c o n t r o l l e d .
Thus, t h e s e newer membranes are
r a t h e r considered t o be u s e f u l f o r u l t r a f i l t r a t i o n therapy.
It i s
a c c o r d i n g l y thought t h a t , f o r hemodialysis u s e , c e l l u l o s i c membranes w i t h a s a t i s f a c t o r y b a l a n c e between water p e r m e a b i l i t y and p e r m e a b i l i t y t o s o l u t e s are t h e most d e s i r a b l e o f a l l t h e c u r r e n t l y a v a i l a b l e membranes.
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I n view o f t h e above c i r c u m s t a n c e s , w e c o n d u c t e d a comp a r a t i v e performance t e s t u s i n g t h r e e d i f f e r e n t c e l l u l o s i c h o l l o w f i b e r d i a l y z e r s , SD-1 ( T a k e d a ) , CF-1500
( T r a v e n o l ) a n d K-102
(Asahi). The c l i n i c a l e v a l u a t i o n o f d i a l y z e r s h a s so f a r b e e n l i m i t e d t o t h e s t u d y o f t h e i r d i a l y s i s p e r f o r m a n c e and o f t h e i r c a p a b i l i t i e s t o remove t h e water, w i t h o u t g i v i n g d u e c o n s i d e r a t i o n t o t h e f a c t o r s which a r e l i k e l y t o i n f l u e n c e t h e r e s u l t o f any c l i n i c a l d i a l y z e r assessment.
T h e r e f o r e , i n c o n d u c t i n g t h e p r e s e n t t e s t , w e formu-
l a t e d a t e s t i n g d e s i g n which seemed t o e n a b l e o n e t o compare t h r e e d i f f e r e n t hollow f i b e r d i a l y z e r s under e q u i v a l e n t c o n d i t i o n s s o t h a t w e might b e a b l e t o h a v e a n a c c u r a t e comparison by a n a l y s e s of v a r i a n c e which t o o k i n t o c o n s i d e r a t i o n t h e t w o f a c t o r s o f p a t i e n t and t i m e , i n a d d i t i o n t o t h e t y p e o f d i a l y z e r .
PATIENTS AND METHODS A.
Patients A t o t a l o f 9 p a t i e n t s , 3 f e m a l e s a n d 6 males were s e l e c t e d
from among t h e c h r o n i c d i a l y s i s p a t i e n t s who had been s u b j e c t e d
175
HOLLOW FIBER DIALYZERS t o 3 d i a l y s e s weekly f o r 5 h o u r s p e r d i a l y s i s a t t h e C e n t r a l Renal U n i t of Konan H o s p i t a l . The p r o f i l e s of t h e p a t i e n t s a r e shown i n Table 1. patient selection criteria:
The
residual renal function 0 (daily
volume of u r i n e < 100 m l ) and c o m p a r a t i v e l y s t a b l e c l i n i c a l cond it i o n .
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A s t o t h e c o m p l i c a t i o n s of each p a t i e n t , Case No. 8: had poor C a metabolism, a l t h o u g h a l l o t h e r cases had no s e r i o u s
complications.
B.
Hollow f i b e r d i a l y z e r s The e f f e c t i v e membrane areas, membrane materials, f i b e r
dimensions, e t c . of t h e 3 test d i a l y z e r s a r e g i v e n i n T a b l e 2. While a l l t h e d i a l y z e r s i n c o r p o r a t e c e l l u l o s i c membranes, SD-1 and CF-1500 u s e Cuprophane membrane manufactured by E m ,
TABLE I Patient
I
Sex
No.
I
M
~~
1
4 5
6 7 8 9
Subjective P a t i e n t s
1 Age -1 I
34.
M M
::
F M M F
50 54 36 33
Diagnosis
I
1 I
c h r o n i c glomerulo nephritis
Dialysis History
1 y e a r 5 months 4 y e a r s 5 months 3 y e a r s 1 month 2 y e a r s 5 months 3 years 4 y e a r s 7 months 2 y e a r s 1 month 3 years10months 4 y e a r s 6 months
NAITO, SHIMIZU, AND HIGASHI
176 TABLE I1
Dialyzer
Company
Area
SD-1
Takeda
1.3 m2
Travenol Asahi
CF-1500 K-102 Ren Fail Downloaded from informahealthcare.com by Osaka University on 11/25/14 For personal use only.
Hollow fiber Dialyzers
Membrane
Thickness
I.D.
Cuprophane
11 urn
200 urn
1.5 m2
Cuprophane
16 urn
215 pm
1.6 m2
Cuproammonium rayon
15 urn
215
urn
West Germany, while K-102 uses the proprietary membrane of Asahi. The effective membrane of these dialyzers are 1.3 m2 for SD-1, 1.5 mL for CF-1500 and 1.6 mL for K-102. As to the dialyzer unit construction, whereas CF-1500 and K-102 are CYlindrical and similar to the hollow fiber dialyzer of Cordis-Dow,
SD-1
has a unique structure, a hollow fiber belt is spirally wound around a central dialysate core. Furthermore, in conducting this test, it was ensured that each group o f dialyzers was taken from a given production lot.
C.
Test Procedure and Design The test was performed with 9 patients over a period of 9
weeks from March, 1978 through May, 1978. The 3 types of test dialyzers were each used 3 times per case as shown in Table 3 and the order of use was S+C+K, C+K+S, K+S+C, each order occurring for 3 cases.
HOLLOW FIBER DIALYZERS
177 Schedule
TABLE 111
I
Term
No.
1
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2 3
4 5 6 7 8
9
I1
I11
1
2
3
4
5
6
7
8
9
K C
C S
K
C
C S
5
K
K
S K C
K
C S
S
S
K C S K C S
C S
S K C S K C S K C
K C
C S
S
K
S
K C S K
K C S K
K C S K
K C S
C
S
C S
K C
C
S
K C S
K
c S K
K C 5
K C 5 K C
J u s t as b e f o r e t h e t e s t , each p a t i e n t w a s s u b j e c t e d t o 3 d i a l y s e s weekly, o n Monday, Wednesday and F r i d a y o r on Tuesday, Thursday and S a t u r d a y , b u t t h e t e s t d i a l y z e r s were used on Wednesday o r Thursday o n l y , w i t h d i a l y s e s on t h e o t h e r weekdays b e i n g c a r r i e d o u t w i t h t h e d i a l y z e r which had been used f o r t h e patient before the test.
It w a s p a r t l y t o e n s u r e t h a t blood
samplings would n o t b e t o o f r e q u e n t and p a r t l y f o r a v o i d i n g t h e i n f l u e n c e of p r o b a b l e c a r r y o v e r e f f e c t s t h a t t h e test d i a l y z e r
w a s used o n l y on one of t h e t h r e e d i a l y s i s days.
On t h e o t h e r
hand, i t w a s n o t u n l i k e l y t h a t t h e c o n d i t i o n of t h e p a t i e n t would change throughout t h i s l o n g test p e r i o d of 9 weeks.
To o b t a i n a n
a c c u r a t e comparison by s e p a r a t i n g t h e i n f l u e n c e of such a t i m e element from e r r o r s , t h e e f f e c t s of d i a l y s i s were e x t r a c t e d f o r each 3 weeks as a term.
178 D.
NAITO, SHIMIZU, AND HIGASHI C o n d i t i o n s of d i a l y s i s The c o n d i t i o n s o f d i a l y s i s w e r e made uniform o v e r a l l t h e
cases:
blood f l o w r a t e 150 ml/min.,
ml/min. and d i a l y s i s t i m e 5 h r s .
d i a l y s a t e f l o w r a t e 500
It w a s a l s o e n s u r e d t h a t t h e
food i n t a k e and m e d i c a t i o n would n o t v a r y t h r o u g h o u t t h e t e s t
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period.
E.
Test items
(1) D i a l y s a n c e s Blood samples w e r e t a k e n from t h e a r t e r i a l and venous s i d e s a b o u t an hour a f t e r t h e s t a r t of d i a l y s i s and the d i a l y s a n c e s of BUN, c r e a t i n i n e , u r i c a c i d and P were e a c h c a l c u l a t e d by means of
the following equation.
Dialysance =
‘Bin-‘Bout ‘Bin
where CBin ‘Bout: QB
(2)
‘B
: C o n c e n t r a t i o n o f s o l u t e s i n a r t e r i a l blood
C o n c e n t r a t i o n of s o l u t e s i n venous blood : Blood f l o w r a t e
UFR
A f t e r d i a l y s a n c e d e t e r m i n a t i o n s , t h e d i a l y s a t e i n l e t and o u t -
l e t of t h e d i a l y z e r were d i s c o n n e c t e d and w i t h t h e mean p r e s s u r e between t h e a r t e r i a l and venous s i d e s b e i n g set a t 200 mmHg, t h e volume of
u l t r a f i l t r a t e o u t of t h e d i a l y s a t e o u t l e t under t h i s
p r e s s u r e d u r i n g 1 0 m i n u t e s w a s measured w i t h a v o l u m e t r i c c y l i n d e r The above measurement was r e p e a t e d f o r a second t i m e and t h e mean w a s m u l t i p l i e d by 6 t o a r r i v e a t UFR p e r a n h o u r .
HOLLOW FIBER DIALYZERS (3)
179
P e r c e n t removal of s o l u t e s
Blood samples were t a k e n b e f o r e and a f t e r d i a l y s i s and t h e p e r c e n t removal of each of BUN, c r e a t i n i n e , u r i c a c i d and P by 5 h o u r s of d i a l y s i s w a s c a l c u l a t e d by means of t h e f o l l o w i n g equation.
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-
% Removal =
Conc. of s o l u t e Conc. of s o l u t e before d i a l y s i s after dialysis Conc. of s o l u t e b e f o r e d i a l y s i s
x 100 ( X )
( 4 ) R e s i d u a l Blood A f t e r e a c h d i a l y s i s and t h e r e c o v e r y of blood from t h e d i a l y z e r , 500 ml of p h y s i o l o g i c a l s a l i n e c o n t a i n i n g 3,000 u n i t s of u r o k i n a s e w a s c i r c u l a t e d through t h e d i a l y z e r f o r about a n hour and t h e hemoglobin c o n c e n t r a t i o n of t h e s a l i n e w a s determined. The r e s i d u a l blood volume w a s t h e n c a l c u l a t e d by means of t h e following equation.
R e s i d u a l blood volume (ml) =
*
Hb of s a l i n e x volume of s a l i n e * Hb of patient after dialysis
Volume of s a l i n e 500 ml-volume of s a l i n e u l t r a f i l t r a t e
RESULTS For each t e s t i t e m , a s i n g l e d a t a was o b t a i n e d f o r each of t h e t h r e e d i a l y z e r s , t e r m s I t o I11 and 9 p a t i e n t s and a 3-way a n a l y s i s of v a r i a n c e w a s c a r r i e d o u t u s i n g t h e d i a l y z e r s and terms
as f i x e d e f f e c t s and t h e p a t i e n t s a s random e f f e c t .
Moreover,
NAITO, SHIMIZU, AND HIGASHI
180
when a significant difference was noted among the three dialyzers, paired comparisons were made by means of Fisher's least significance difference method.
(1) Dialysances The three-way analysis of variance showed no significant Ren Fail Downloaded from informahealthcare.com by Osaka University on 11/25/14 For personal use only.
difference among dialyzers, among terms of among patients as for creatinine, uric acid and P dialysances. Regarding BUN dialysance, while there was no significant difference among terms or among patients, a significant difference (p