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Saudi Journal of Kidney Diseases and Transplantation
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ORIGINAL ARTICLE Table of Contents   
Year : 2000  |  Volume : 11  |  Issue : 4  |  Page : 543-547
The Effect of Vitamin E-Modified Dialyzers on Acute Intra-dialytic Symptoms: A Comparative Crossover Study


1 Department of Medicine, King Fahad National Guard Hospital, Saudi Arabia
2 Saudi Center for Organ Transplantation, Riyadh, Saudi Arabia
3 Nursing Department, King Fahad National Guard Hospital, Saudi Arabia

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   Abstract 

We performed a crossover study to compare the effect of vitamin E-modified dialyzers on acute intra-dialytic symptoms, with other membranes. Twenty patients on hemodialysis were studied. They were divided into two equal groups of low-flux (C15NL, E15NL) and high-flux (F60, EE15NL) membrane dialyzers. Within each group, a vitamin E-modified dialyzer was compared with another dialyzer in a crossover design over a two­month period. All study patients were seen during each dialysis session by a physician and the occurrence of intra-dialytic symptoms were recorded. There was a significant overall improvement in the incidence of acute intra-dialytic symptoms with the use of vitamin E­modified dialyzers as compared with the other membranes. This effect was more for cuprophane than polysulfone. The occurrence of hypotensive episodes did not differ. Our study indicates that we can achieve a reduction in the incidence of acute intra-dialytic symptoms with the use of vitamin E-modified membrane as compared to cuprophane and polysulfone.

Keywords: Vitamin E-modified dialyzers, Acute intra-dialytic symptoms, Cuprophane, Polysulfone.

How to cite this article:
Tanimu D, Huraib S, Shaheen FA, Hejaili F, Giles C, Pagayon V. The Effect of Vitamin E-Modified Dialyzers on Acute Intra-dialytic Symptoms: A Comparative Crossover Study. Saudi J Kidney Dis Transpl 2000;11:543-7

How to cite this URL:
Tanimu D, Huraib S, Shaheen FA, Hejaili F, Giles C, Pagayon V. The Effect of Vitamin E-Modified Dialyzers on Acute Intra-dialytic Symptoms: A Comparative Crossover Study. Saudi J Kidney Dis Transpl [serial online] 2000 [cited 2019 Nov 12];11:543-7. Available from: http://www.sjkdt.org/text.asp?2000/11/4/543/36640

   Introduction Top


During hemodialysis a number of acute complications including intra-dialytic hypo­tension, nausea, vomiting, headache, muscle cramps as well as fatigue at the end of dialysis session could occur. [1],[2],[3] The type of membrane used during dialysis may be important in causing some of these complications. [4] Biochemical and cellular mechanisms that are triggered off secondary to blood-membrane interaction probably play a role in the genesis of these symptoms. [5],[6],[7] Previous reports have shown that cellulosic membranes activate these pathways to a greater extent than biocompatible memb-ranes. [5],[6],[8] Accordingly, selection of the appropriate membrane has become an increasingly important element in the dialysis prescription. Additionally, hemodialysis has been demonstrated to generate oxygen free­radicals (OFR) as a consequence of the membrane material used. [9] Vitamin E­modified dialyzers were introduced in an attempt to improve the quality of hemodialysis filters with the double goal of improving biocom-patibility as well as protecting against OFR.

In the present study, we report the results of a crossover study comparing vitamin E­modified membranes to other membranes with respect to intra-dialytic symptoms.


   Patients and Methods Top


Twenty patients (10 males, 10 females), on three times per week maintenance hemo­dialysis for a mean duration of 26 + 5.2 months, were recruited for the study. Patients were stable on dialysis for at least four weeks prior to the commencement of the study without any acute illnesses. Written informed consent was obtained from all participants. The patients were then equally divided into two groups to receive dialysis therapy with either high- or low-flux memb-ranes with similar dialysis performance. Within each group, a vitamin E-modified dialyzer was compared to another dialyzer in a crossover design.

Low-flux dialyzers used were C15NL (cellulose, Terumo) and E15NL (vitamin E­modified, Terumo), while high-flux dialyzers were F60 (polysulfone) and EE15NL (vitamin E-modified, Terumo). Ten patients underwent dialysis for two months with C15NL dialyzers and were subsequently switched to E15NL dialyzers which were used for the next two months. Similarly, the other 10 patients were treated with F60 dialyzers for two months and then switched to EE15NL dialyzers for the next two months.

All the patients were seen by a physician during each dialysis session. Observations on intra-dialytic symptoms and signs made by the staff during the course of each treatment were entered into the dialysis record. The various symptoms were recorded as either present or absent. Hypotension was defined as systolic blood pressure (SBP) less then 100 mm Hg or a drop in SBP by > 25 mm Hg, accompanied by symptoms.


   Statistics Top


The statistical package SIGMA STAT, 1993, was used to analyze the data. Analysis was carried out using chi square test with p < 0.05 considered significant.


   Results Top


All the 20 recruited patients completed the study. Their mean age was 52 + 9 years (range 26-60 years) and the mean duration on dialysis was 26 + 5.2 months. The primary renal disease of the study patients was as follows: chronic glomerulonephritis n=6, diabetic nephropathy n=3, chronic pyelo­nephritis n=3, unknown n=8. All patients received erythropoietin throughout the study period. There was an improvement in the overall intra-dialytic well being with the use of vitamin E-modified dialyzers as compared to cuprophane and polysulfone membranes. There was a statistically signi­ficant reduction in the incidence of the subset of "biocompatibility symptoms", such as chest pain, back pain and itching, with the use of E15NL as compared to C15NL, p < 0.05 [Table - 1].

Also, the occurrence of muscle cramps, nausea, vomiting and headache was signi­ficantly less with the vitamin E-modified membrane, E15NL. Although there was a tendency towards occurrence of less hypo­tensive episodes during dialysis with the use of vitamin E-modified membrane, this did not reach statistical significance. Two patients dialyzed with C15NL developed hypersensitivity reactions characterized by fever and chills. A modest overall improve­ment was also seen with the use of EE15NL as compared to F60 dialyzer. Patients on EE15NL experienced less chest pain, back pain and muscle cramps as compared to F60, p < 0.05 [Table - 2]. The incidence of itching, hypotension, nausea, vomiting and headache were not different between the two membranes. No episodes of hypersensitivity reactions were observed with either EE15NL or F60 dialyzers.


   Discussion Top


Hemodialysis, a life saving procedure for patients with end-stage renal disease, is associated with a number of acute intra­dialytic complications and symptoms such as hypotension, chest pain, back pain, muscle cramps, nausea, vomiting, headache, pruritus, and fatigue. The etiology of these symptoms is multifactorial and may result from blood-membrane interaction. [5],[6],[7],[8] In a crossover design, we studied the incidence of intra-dialytic symptoms in patients treated with the new vitamin E-modified dialyzers and compared the same with the use of other membranes. The results of this study showed a significant improvement in most of the intra-dialytic symptoms and an overall patient well-being when the vitamin E-modified dialyzers were used as compared to cuprophane and polysulfone membranes.

A few previous studies (not using vitamin E-modified membranes) have shown that there is no effect of membrane biocompatibility on symptoms during hemodialysis. [10],[11],[12],[13] Thus, Skroeder et al [10] showed no difference between using cuprophane, hemophane or polyamide membrane in the occurrence of intra-dialytic symptoms. The Bergamo Collaborative Dialysis Study Group [11] found no difference between cuprophane and high-flux polysulfone membrane. Similarly, Collins et al [12] did not find a significant difference in intra-dialytic symptoms between polyacrylonitrile and cuprophane membranes.

However, other reports have related the degree of biocompatibility of the dialyzer membrane, as expressed by the development of leucopenia and complement activation, with the development of intra­dialytic symptoms. [14],[15] The vitamin E­-modified dialyzers have been shown to cause less leukopenia and complement activation, [16] which might explain the significantly reduced incidence of intra­dialytic symptoms. We could not show any difference in the incidence of hypotension with the vitamin E-modified membranes, suggesting that hypotension may not necessarily be linked with biocompatibility. The vitamin E-modified membrane consists of three elements; a block polymer which masks the hydroxyl groups on cellulose, an oleyl alcohol that inhibits platelet aggre­gation and a vitamin E coating with anti­oxidant properties. Oxygen free radicals may play a pathogenic role in some hemo­dialysis related complications. [17] The vitamin E-modified membrane, in addition to anti-oxidant properties, has improved biocompatibility characteristics due to its multi-layered design aimed at limiting blood-membrane interaction.

These new dialyzers could be considered more biocompatible than other membranes because of their minimal inflammatory-type reaction with blood. Biocompatibility may affect not only acute intra-dialytic events, but could also have an impact on the long­term morbidity and complications. [18]

In summary, our study suggests that the use of vitamin E-modified dialyzers produces a significant improvement in intra-dialytic symptoms and overall patient well being when compared to cuprophane or polysulfone membranes.

 
   References Top

1.Daugirdas JT. Dialysis hypotension: a hemo­dynamic analysis. Kidney Int 1991;39:233-46.  Back to cited text no. 1  [PUBMED]  
2.Campese VM. Cardiovascular instability during hemodialysis. Kidney Int 1988;24: S186-90.  Back to cited text no. 2    
3.Canzanello VJ, Burkart JM. Hemodialysis associated muscle cramps. Semin Dial 1992;5:299-301.  Back to cited text no. 3    
4.Levin NW, Zasuwa G. Relationship between dialyzer type and signs and symptoms. Nephrol Dial Transplant 1993;8(Suppl 2): 30-9.  Back to cited text no. 4  [PUBMED]  
5.Hakim RM. Clinical implications of hemodialysis membrane biocompatibility. Kidney Int 1993;44:484-94.  Back to cited text no. 5  [PUBMED]  
6.Klinkmann H, Vienken J. Membranes for dialysis. Nephrol Dial Transplant 1995; 10(Suppl 3):39-45.  Back to cited text no. 6  [PUBMED]  
7.Lundberg L, Johansson G, Karlsson L, Stegmayr BG. Complement activation is influenced by the membrane material, design of the dialyzer, sterilizing method, and type of dialysate. Nephrol Dial Transplant 1994;9:1310-4.  Back to cited text no. 7  [PUBMED]  [FULLTEXT]
8.Seyfert UT, Helmling E, Hauck W, Skroch D, Albert W. Comparison of blood bio­compatibility during hemodialysis with cuprophane and polyacrylonitrile mem­branes. Nephrol Dial Transplant 1991;6: 428-34.  Back to cited text no. 8  [PUBMED]  
9.Cristol JP, Canaud B, Rabesandratana H, Gaillard I, Serre A, Mion C. Enhancement of reactive oxygen species production and cell surface markers expression due to hemodialysis. Nephrol Dial Transplant 1994;9:389-94.  Back to cited text no. 9  [PUBMED]  [FULLTEXT]
10.Skroeder NR, Jacobson SH, Lins LE, Kjellstrand CM. Biocompatibility of dialysis membranes is of no importance for objective or subjective symptoms during or after hemodialysis. Am Soc Artif Intern Organs Trans 1990;36:M634-9.  Back to cited text no. 10    
11.Bergamo Collaborative Dialysis Study Group. Acute intradialytic well-being: results of a clinical trial comparing polysulfone with cuprophane. Kidney Int 1991;40:714-9.  Back to cited text no. 11  [PUBMED]  
12.Collins DM, Lambert MB, Tannenbaum JS, Oliverio M, Schwab SJ. Tolerance of hemodialysis: a randomized prospective trial of high-flux versus conventional high­efficiency hemodialysis. J Am Soc Nephrol 1993;4:148-54.  Back to cited text no. 12  [PUBMED]  
13.Churchill DN, Bird DR, Taylor DW, Beecroft ML, Gorman J, Wallace JE. Effect of high flux hemodialysis on quality of life and neuropsychological function in chronic hemodialysis patients. Am J Nephrol 1992;12:412-8.  Back to cited text no. 13  [PUBMED]  
14.Villarroel F. Incidence of hypersensitivity in hemodialysis. Artif Organs 1984;8:278-80.  Back to cited text no. 14  [PUBMED]  
15.Dumler F, Levin NW. Membrane biocom­patibility: clinical significance and thera­peutic implications. Int J Artif Organs 1985;8:257-62.  Back to cited text no. 15  [PUBMED]  
16.Saruhashi M, Watanabe H, Sasaki M. Biocompatibility of vitamin E modified regenerated cellulose. Jpn J Artif Organs 1995;24:631-6.  Back to cited text no. 16    
17.Buoncristiani U, Galli F, Rovidati S, Albertini MC, Campus G, Canestrari F. Oxidative damage during hemodialysis using a vitamin-E-modified dialysis membrane: a preliminary characterization. Nephron 1997;77:57-61.  Back to cited text no. 17  [PUBMED]  
18.Locatelli F. Influence of membranes on morbidity. Nephrol Dial Transplant 1996; 11(Suppl 2):116-20.  Back to cited text no. 18  [PUBMED]  

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Correspondence Address:
Sameer Huraib
Department of Medicine, King Fahad National Guard Hospital, P.O. Box 22490, Riyadh 11426
Saudi Arabia
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PMID: 18209342

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    Abstract
    Introduction
    Patients and Methods
    Statistics
    Results
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    References
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