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Randomized Controlled Trial
. 2013 Feb;24(3):487-97.
doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.

High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients

Collaborators, Affiliations
Randomized Controlled Trial

High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients

Francisco Maduell et al. J Am Soc Nephrol. 2013 Feb.

Erratum in

  • J Am Soc Nephrol. 2014 May;25(5):1130

Abstract

Retrospective studies suggest that online hemodiafiltration (OL-HDF) may reduce the risk of mortality compared with standard hemodialysis in patients with ESRD. We conducted a multicenter, open-label, randomized controlled trial in which we assigned 906 chronic hemodialysis patients either to continue hemodialysis (n=450) or to switch to high-efficiency postdilution OL-HDF (n=456). The primary outcome was all-cause mortality, and secondary outcomes included cardiovascular mortality, all-cause hospitalization, treatment tolerability, and laboratory data. Compared with patients who continued on hemodialysis, those assigned to OL-HDF had a 30% lower risk of all-cause mortality (hazard ratio [HR], 0.70; 95% confidence interval [95% CI], 0.53-0.92; P=0.01), a 33% lower risk of cardiovascular mortality (HR, 0.67; 95% CI, 0.44-1.02; P=0.06), and a 55% lower risk of infection-related mortality (HR, 0.45; 95% CI, 0.21-0.96; P=0.03). The estimated number needed to treat suggested that switching eight patients from hemodialysis to OL-HDF may prevent one annual death. The incidence rates of dialysis sessions complicated by hypotension and of all-cause hospitalization were lower in patients assigned to OL-HDF. In conclusion, high-efficiency postdilution OL-HDF reduces all-cause mortality compared with conventional hemodialysis.

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Figures

Figure 1.
Figure 1.
Flow chart of study populations, including the number of patients who were screened, underwent randomization, and completed the study treatment or presented the primary variable. HD, hemodialysis.
Figure 2.
Figure 2.
Kaplan–Meier curves for 36-month survival in the intention-to-treat population (P=0.01 by the log-rank test). HD, hemodialysis.
Figure 3.
Figure 3.
Sensitivity analyses for the main outcome showing HRs (95% CIs) for the intervention based on relevant variables that were found to be independent predictors for all-cause mortality. Multivariate I, age, sex, vascular access, diabetes, and the Charlson comorbidity index (excluding diabetes); multivariate II, age, sex, vascular access, and the Charlson comorbidity index (excluding diabetes); multivariate III, age, sex, vascular access, and diabetes; multivariate IV, age, sex, vascular access, and the Charlson comorbidity index (including diabetes); Y, yes; N, no; Cath, catheter; Fist, fistula; M, male; F, female; T1, T2, and T3, first, second, and third tertiles; HD, hemodialysis.

Comment in

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