Randomized trial of FX high flux vs standard high flux dialysis for homocysteine clearance

Mudge, David W., Rogers, Robyn, Hollett, Peter, Law, Belinda, Reiger, Kylie, Petrie, James J. B., Price, Lee, Johnson, David W., Campbell, Scott B., Isbel, Nicole M., Sullivan, Matthew and Hawley, Carmel M. (2005) Randomized trial of FX high flux vs standard high flux dialysis for homocysteine clearance. Nephrology Dialysis Transplantation, 20 10: 2178-2185. doi:10.1093/ndt/gfh987


Author Mudge, David W.
Rogers, Robyn
Hollett, Peter
Law, Belinda
Reiger, Kylie
Petrie, James J. B.
Price, Lee
Johnson, David W.
Campbell, Scott B.
Isbel, Nicole M.
Sullivan, Matthew
Hawley, Carmel M.
Title Randomized trial of FX high flux vs standard high flux dialysis for homocysteine clearance
Journal name Nephrology Dialysis Transplantation   Check publisher's open access policy
ISSN 0931-0509
1460-2385
Publication date 2005
Sub-type Article (original research)
DOI 10.1093/ndt/gfh987
Volume 20
Issue 10
Start page 2178
End page 2185
Total pages 8
Editor T. B. Drueke
Place of publication Oxford, United Kingdom
Publisher Oxford University Press
Collection year 2005
Language eng
Subject C1
730118 Organs, diseases and abnormal conditions not elsewhere classified
110312 Nephrology and Urology
Formatted abstract
Background. Cardiovascular disease is the major cause of death in the end-stage renal disease population. Novel risk factors such as homocysteine (Hcy) are of considerable interest in this group as hyperhomocysteinaemia is highly prevalent in the setting of renal impairment. Folic acid–vitamin B group therapies are only partially effective treatments. Hcy is highly protein-bound and thus poorly dialysed. Dialyzers with albumin-leaking properties have been shown to result in lowering of plasma Hcy. As the FX-class (Advanced Fresenius Polysulfone dialyzer) has greater clearance of larger molecular weight substances but is non-albumin-leaking, we explored the capacity of this new technology membrane to reduce plasma Hcy levels.

Methods. A prospective randomized cross-over trial in 35 prevalent haemodialysis patients, one group receiving 12 weeks dialysis using FX dialyzer then 12 weeks with standard high flux dialysis (SHF) and the other group SHF followed by FX dialyzer. All patients received vitamin B6 25 mg and folic acid 5 mg daily throughout the study.

Results. The primary outcome was plasma Hcy pre-dialysis at week 12. FX vs SHF showed no significant difference, 25±6.6 vs 25.9±5.8 µg/l, {Delta}95% CI = –2.77 to 4.59, P = 0.31. There was a non-significant trend toward a decrease in Hcy in both groups (27.43±7.68 to 25.91±5.78 µmol/l for SHF, P = 0.23 and 26.0±4.58 to 25.0±6.61 µmol/l for FX, P = 0.28). Analysis by repeated measures method demonstrated a statistically significantly lower Hcy with FX vs SHF dialyzer (adjusted ß = –1.30, 95% CI = –2.41 to –0.19, P = 0.022). Kt/Vurea was higher in FX vs SHF (1.35±0.18 vs 1.22±0.2; P = 0.013). Folate and B6 levels did not change.

Conclusions. The primary outcome analysis did not show any significant difference in pre-Hcy comparing FX and SHF membranes. Although our secondary analysis demonstrated a statistically significant difference between membranes, the magnitude of the difference (1.3 µmol/l) is not clinically significant. Thus the use of the FX dialyzer did not result in a clinically significant benefit in relation to improving pre-dialysis Hcy compared with standard high-flux dialysis.
Keyword Transplantation
Urology & Nephrology
Dialyzer Membrane
Dialysis
Fx-class Dialyzer
Haemodialysis
High-flux
Plasma Homocysteine
Hemodialysis-patients
Risk-factor
Vascular-disease
Hyperhomocysteinemia
Membranes
Dialyzers
Profiles
Q-Index Code C1
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
2006 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Wed, 15 Aug 2007, 05:39:21 EST