High-Volume HDF & reduced mortality
Study Design and Methods
Aim: To investigate whether high-dose HDF offers survival benefits as compared with conventional high-flux HD.
Patients: 1360 patients from 61 dialysis centers in eight European countries, treated with high-flux HD, and deemed to be candidates for a convection volume of at least 23 L per session.
Design: A pragmatic, 1:1 randomized controlled trial with outcomes assessed over 30 months (median). 683 patients were assigned to online high-volume HDF and 677 patients to high-flux HD. High-volume HDF means post-dilution HDF with online production of fluids and convection volume ≥ 23 L per session.
Method: Convection volume targets achieved with stepwise adjustment over 2-3 weeks; interventions and outcomes assessed over 30 months (median)
Primary outcome: Death from any cause.
Secondary outcome: Key secondary outcomes were cause-specific mortality, composite of fatal and nonfatal cardiovascular events, kidney transplantation, and recurrent hospitalizations for any cause and for causes related to infection
Results
Primary outcome:
Death from any cause occurred in 118 patients (17.3%) in the HDF group and in 148 patients (21.9%) in the HD group. Patients in the HDF group had a 23% lower rate of mortality (hazard ratio (HR), 0.77; 95% confidence interval (CI), 0.65- 0.93; P = 0.005).
Secondary outcome:
- The risk of death from cardiovascular causes and the composite outcome of fatal or nonfatal cardiovascular outcomes were similar in the HDF and the HD group; with a reduction of infection-related death in favor of high-dose HDF, including from Covid-19 (HR, 0.69; 95% CI, 0.49 to 0.96).
- The Kt/V value over the course of the trial was higher in the HDF group than in the HD group (1.74 vs. 1.65).
- The target convection volume of at least 23 L was achieved in 92% of delivered HDF sessions, with a stable mean convection volume of 25.2 L over the course of the trial.
Conclusions
The CONVINCE study found a lower risk of death from any cause in patients receiving high-volume HDF than among patients receiving high-flux HD. Infection-related and cardiovascular deaths showed a suggestion of benefit for HDF. The study differs from previous studies in that it enrolled patients who were likely candidates for high-dose HDF nearly all the time. It did not identify an association between failure to achieve the high-dose target and any particular patient characteristic or vascular access type. The trial results support the evidence that high-volume HDF can result in a clinically important survival benefit.
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2 Blankestijn PJ et al., CONVINCE Scientific Committee Investigators, Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure, N Engl J Med 2023 Aug 24;389(8):700-709