title: The impact of membrane permeability and dialysate purity on cardiovascular outcomes.
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.
authors.affiliation: Department of Biostatistics, Ege University School of Medicine, Izmir, Turkey. gulayas@hotmail.com
authors.forename: Gulay
authors.initials: G
authors.lastname: Asci
authors.forename: Huseyin
authors.initials: H
authors.lastname: Tz
authors.forename: Mehmet
authors.initials: M
authors.lastname: Ozkahya
authors.forename: Soner
authors.initials: S
authors.lastname: Duman
authors.forename: Meltem Sezis
authors.initials: MS
authors.lastname: Demirci
authors.forename: Mustafa
authors.initials: M
authors.lastname: Cirit
authors.forename: Savas
authors.initials: S
authors.lastname: Sipahi
authors.forename: Hamad
authors.initials: H
authors.lastname: Dheir
authors.forename: Devrim
authors.initials: D
authors.lastname: Bozkurt
authors.forename: Fatih
authors.initials: F
authors.lastname: Kircelli
authors.forename: Ebru Sevinc
authors.initials: ES
authors.lastname: Ok
authors.forename: Sinan
authors.initials: S
authors.lastname: Erten
authors.forename: Muhittin
authors.initials: M
authors.lastname: Ertilav
authors.forename: Timur
authors.initials: T
authors.lastname: Kose
authors.forename: Ali
authors.initials: A
authors.lastname: Basci
authors.forename: Jochen G
authors.initials: JG
authors.lastname: Raimann
authors.forename: Nathan W
authors.initials: NW
authors.lastname: Levin
authors.forename: Ercan
authors.initials: E
authors.lastname: Ok
mesh_terms: D000328:Adult; D000368:Aged; D001166:Arteriovenous Shunt, Surgical / Q000706:statistics & numerical data; D002318:Cardiovascular Diseases / Q000401:mortality*; D048909:Diabetes Complications / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000401:mortality; D015312:Hemodialysis Solutions / Q000592:standards*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000401:mortality* / Q000628:therapy*; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D015995:Prevalence; D016016:Proportional Hazards Models; D006435:Renal Dialysis / Q000379:methods / Q000401:mortality* / Q000592:standards*; D012307:Risk Factors
chemical_list: D015312:Hemodialysis Solutions; D008567:Membranes, Artificial