Blankestijn Peter J, Vernooij Robin W M, Hockham Carinna, Strippoli Giovanni F M, Canaud Bernard, Hegbrant Jörgen, Barth Claudia, Covic Adrian, Cromm Krister, Cucui Andrea, Davenport Andrew, Rose Matthias, Török Marietta, Woodward Mark, Bots Michiel L
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):700-709. doi: 10.1056/NEJMoa2304820. Epub 2023 Jun 16.
Several 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.
We 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.
A 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).
In 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.).
多项研究表明,与标准血液透析相比,肾衰竭患者可能从高剂量血液透析滤过中获益。然而,鉴于已发表的各项研究存在局限性,仍需要更多数据。
我们进行了一项务实的、多国的、随机对照试验,纳入了接受高通量血液透析至少3个月的肾衰竭患者。所有患者均被认为适合每次透析对流体积至少23升(高剂量血液透析滤过所需),并且能够完成患者报告的结局评估。患者被随机分配接受高剂量血液透析滤过或继续进行传统高通量血液透析。主要结局是任何原因导致的死亡。关键次要结局是特定原因死亡、致命或非致命心血管事件的综合、肾移植以及全因或感染相关再住院。
共有1360例患者被随机分组:683例接受高剂量血液透析滤过,677例接受高通量血液透析。中位随访时间为30个月(四分位间距,27至38个月)。血液透析滤过组在试验期间的平均对流体积为每次透析25.3升。血液透析滤过组有118例患者(17.3%)因任何原因死亡,血液透析组有148例患者(21.9%)死亡(风险比,0.77;95%置信区间,0.65至0.93)。
在需要肾脏替代治疗的肾衰竭患者中,使用高剂量血液透析滤过比传统高通量血液透析导致任何原因死亡的风险更低。(由欧盟委员会研究与创新资助;CONVINCE荷兰试验注册号,NTR7138。)