• N. Engl. J. Med. · Aug 2023

    Randomized Controlled Trial Pragmatic Clinical Trial

    Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure.

    • Peter J Blankestijn, Robin W M Vernooij, Carinna Hockham, StrippoliGiovanni F MGFMFrom the Department of Nephrology and Hypertension (P.J.B., R.W.M.V.) and the Julius Center for Health Sciences and Primary Care (R.W.M.V., M.L.B.), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; G, Bernard Canaud, Jörgen Hegbrant, Claudia Barth, Adrian Covic, Krister Cromm, Andrea Cucui, Andrew Davenport, Matthias Rose, Marietta Török, Mark Woodward, Michiel L Bots, and CONVINCE Scientific Committee Investigators.
    • From the Department of Nephrology and Hypertension (P.J.B., R.W.M.V.) and the Julius Center for Health Sciences and Primary Care (R.W.M.V., M.L.B.), University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; George Institute for Global Health, School of Public Health, Imperial College London (C.H., M.W.), and the Department of Renal Medicine, Royal Free Hospital, Division of Medicine, University College London (A.D.) - both in London; the Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Bari, Italy (G.F.M.S.); the School of Public Health, University of Sydney (G.F.M.S.), and the George Institute for Global Health, University of New South Wales (M.W.) - both in Sydney; Montpellier University School of Medicine, Montpellier, France (B.C.); Fresenius Medical Care Deutschland, Global Medical Office, Bad Homburg, Germany (B.C., K.C.), Medical Scientific Affairs, B. Braun Avitum, Melsungen (C.B.), and Charité Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and the Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin Institute of Health, Berlin (K.C., M.R.) - all in Germany; the Division of Nephrology, Department of Clinical Sciences, Lund University, Lund (J.H.), and Corporate Medical Office Diaverum, Malmö (M.T.) - both in Sweden; and the Department of Nephrology, Grigore T. Popa University of Medicine, Iasi (A. Covic), and Fresenius Nephocare Dialysis Center, Bucharest (A. Cucui, A. Covic) - both in Romania.
    • N. Engl. J. Med. 2023 Aug 24; 389 (8): 700709700-709.

    BackgroundSeveral studies have suggested that patients with kidney failure may benefit from high-dose hemodiafiltration as compared with standard hemodialysis. However, given the limitations of the various published studies, additional data are needed.MethodsWe conducted a pragmatic, multinational, randomized, controlled trial involving patients with kidney failure who had received high-flux hemodialysis for at least 3 months. All the patients were deemed to be candidates for a convection volume of at least 23 liters per session (as required for high-dose hemodiafiltration) and were able to complete patient-reported outcome assessments. The patients were assigned to receive high-dose hemodiafiltration or continuation of conventional high-flux hemodialysis. The primary outcome was death from any cause. Key secondary outcomes were cause-specific death, a composite of fatal or nonfatal cardiovascular events, kidney transplantation, and recurrent all-cause or infection-related hospitalizations.ResultsA total of 1360 patients underwent randomization: 683 to receive high-dose hemodiafiltration and 677 to receive high-flux hemodialysis. The median follow-up was 30 months (interquartile range, 27 to 38). The mean convection volume during the trial in the hemodiafiltration group was 25.3 liters per session. Death from any cause occurred in 118 patients (17.3%) in the hemodiafiltration group and in 148 patients (21.9%) in the hemodialysis group (hazard ratio, 0.77; 95% confidence interval, 0.65 to 0.93).ConclusionsIn patients with kidney failure resulting in kidney-replacement therapy, the use of high-dose hemodiafiltration resulted in a lower risk of death from any cause than conventional high-flux hemodialysis. (Funded by the European Commission Research and Innovation; CONVINCE Dutch Trial Register number, NTR7138.).Copyright © 2023 Massachusetts Medical Society.

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