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Randomized Controlled Trial
. 2013 May;24(6):1014-23.
doi: 10.1681/ASN.2012090908. Epub 2013 Apr 25.

The impact of membrane permeability and dialysate purity on cardiovascular outcomes

Gulay Asci  1 , Huseyin Tz, Mehmet Ozkahya, Soner Duman, Meltem Sezis Demirci, Mustafa Cirit, Savas Sipahi, Hamad Dheir, Devrim Bozkurt, Fatih Kircelli, Ebru Sevinc Ok, Sinan Erten, Muhittin Ertilav, Timur Kose, Ali Basci, Jochen G Raimann, Nathan W Levin, Ercan Ok; EGE Study Group
Collaborators, Affiliations
Randomized Controlled Trial

The impact of membrane permeability and dialysate purity on cardiovascular outcomes

Gulay Asci et al. J Am Soc Nephrol. 2013 May.

Abstract

The effects of high-flux dialysis and ultrapure dialysate on survival of hemodialysis patients are incompletely understood. We conducted a randomized controlled trial to investigate the effects of both membrane permeability and dialysate purity on cardiovascular outcomes. We randomly assigned 704 patients on three times per week hemodialysis to either high- or low-flux dialyzers and either ultrapure or standard dialysate using a two-by-two factorial design. The primary outcome was a composite of fatal and nonfatal cardiovascular events during a minimum 3 years follow-up. We did not detect statistically significant differences in the primary outcome between high- and low-flux (HR=0.73, 95% CI=0.49 to 1.08, P=0.12) and between ultrapure and standard dialysate (HR=0.90, 95% CI=0.61 to 1.32, P=0.60). Posthoc analyses suggested that cardiovascular event-free survival was significantly better in the high-flux group compared with the low-flux group for the subgroup with arteriovenous fistulas, which constituted 82% of the study population (adjusted HR=0.61, 95% CI=0.38 to 0.97, P=0.03). Furthermore, high-flux dialysis associated with a lower risk for cardiovascular events among diabetic subjects (adjusted HR=0.49, 95% CI=0.25 to 0.94, P=0.03), and ultrapure dialysate associated with a lower risk for cardiovascular events among subjects with more than 3 years of dialysis (adjusted HR=0.55, 95% CI=0.31 to 0.97, P=0.04). In conclusion, this trial did not detect a difference in cardiovascular event-free survival between flux and dialysate groups. Posthoc analyses suggest that high-flux hemodialysis may benefit patients with an arteriovenous fistula and patients with diabetes and that ultrapure dialysate may benefit patients with longer dialysis vintage.

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Figures

Figure 1.
Figure 1.
Comparison of fatal and nonfatal cardiovascular event-free survival in treatment arms. (A) high-flux/low-flux dialyzers and (B) ultrapure/standard dialysate.
Figure 2.
Figure 2.
Cardiovascular event-free survival in subgroups analysis. (A) patients with AVF and (B) HD duration longer than 3 years.
Figure 3.
Figure 3.
Cardiovascular event-free survival and overall survival. (A) event-free survival and (B) overall survival among the combination of treatment arms.
Figure 4.
Figure 4.
Flow chart of the study.
See this image and copyright information in PMC

Comment in

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