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Autore Ercan Ok,1 Gulay Asci,1 Ebru Sevinc Ok,1 Fatih Kircelli,1 Mumtaz Yilmaz,1 Ender Hur,1 Meltem Sezis Demirci,1 Oner Ozdogan,1 Cenk Demirci,1 Ozen Onen Sertoz,1 Soner Duman,1 Mehmet Ozkahya,1 Meral Kayikcioglu,1 Hayriye Elbi,1 Ali Basci,1 Huseyin Toz1. 1Nephrology, Ege University School of Medicine, Izmir, Bornova, Turkey
Contenuto INTRODUCTION AND AIMS: On-line hemodiafiltration (HDF) may confer clinical benefits over conventional hemodialysis (HD) in terms of solute removal. The aim of this study was to compare postdilution online-HDF and high-flux HD regarding morbidity and mortality. METHODS: In this prospective, randomized, controlled trial, we enrolled 782 patients undergoing thrice-weekly HD and randomly assigned them in a 1:1 ratio to either postdilution online-HDF or high-flux HD. Mean age was 56.5±13.9 years, time on HD 57.9±44.6 months, diabetes 34.7%. Follow-up period was 2 years. Primary outcome was composite of death from any cause and non-fatal cardiovascular events. The major secondary outcomes were cardiovascular and overall mortality, intradialytic complications, hospitalization rate, changes in laboratory parameters and medications. Echocardiography, pulse wave analysis, bioimpedance analysis and psychometric measurements were performed at the baseline, 12th and 24th month. RESULTS: Mean follow-up was 22.7±10.9 months. Mean substitution volume was 17.2±1.3 L. Despite a trend favoring HDF, primary outcome (84.4% in the HDF versus 81.3% in the HD group, p=0.28), as well as cardiovascular and overall survival, hospitalization rate and number of hypotensive episodes, were not different between the groups. There was also no difference between the two groups at the baseline and at the end of the study regarding psychometric measurements, echocardiography, pulse wave analysis and bioimpedance parameters. Despite similar time-averaged hemoglobin levels, prescribed erythropoietin dose was lower in the HDF group compared to the HD group. Urea reduction rate, bicarbonate and HDL were higher, while albumin and triglyceride were lower in the HDF group. In the subgroup of HDF patients treated with a substitution volume over 17.4 L per session (n=195), cardiovascular and overall survival were better than both the HDF subgroup with substitution volume ≤17.4 L (n=196) (p=0.03) and the HD group (p=0.002). Primary outcome was similar in these 3 groups (85.2%, 83.8% and 81.2%, respectively, p=0.26). In adjusted Cox-regression analysis, HDF with substitution volume over 17.4 L was associated with a 46% risk reduction for overall mortality [RR=0.54 (95% CI 0.31-0.93), p=0.02] and a 71% risk reduction for cardiovascular mortality [RR=0.29 (95% CI 0.12-0.65), p=0.003] compared to HD. CONCLUSIONS: Composite of death from any cause and non-fatal cardiovascular events is not different between postdilution on-line HDF and high-flux HD. HDF treatment with substitution volume over 17.4 L provides better cardiovascular and overall survival compared to HD.
Data 30.06.2011
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