The High-volume Haemodiafiltration vs High-flux Haemodialysis Registry Trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes.

Abstract

Background More than a third of the 65,000 people living with kidney failure in the UK attend a dialysis unit 2–5 times a week to have their blood cleaned for 3–5 hours. In haemodialysis (HD) toxins are removed by diffusion, which can be enhanced using a high-flux dialyser. This can be augmented with convection, as occurs in haemodiafiltration (HDF) and improved outcomes have been reported in people who are able to achieve high volumes of convection. This study compares the clinical- and cost-effectiveness of high-volume HDF compared with high-flux HD in the treatment of kidney failure. Methods This is a UK-based, multi-centre, non-blinded randomised controlled trial. Adult patients already receiving HD or HDF will be randomised 1:1 to high-volume HDF (aiming for 21 + L of substitution fluid adjusted for body surface area) or high-flux HD. Exclusion criteria include lack of capacity to consent, life expectancy less than 3 months, on HD/HDF for less than 4 weeks, planned living kidney donor transplant or home dialysis scheduled within 3 months, prior intolerance of HDF, and not suitable for high-volume HDF for other clinical reasons. The primary outcome is a composite of non-cancer mortality or hospital admission with a cardiovascular event or infection during follow-up (minimum 32 months, maximum 91 months) determined from routine data. Secondary outcomes include all-cause mortality, cardiovascular and infection related morbidity and mortality, health-related quality of life, cost-effectiveness and environmental impact. Baseline data will be collected by research personnel on-site. Follow up data will be collected by linkage to routine healthcare databases – Hospital Episode Statistics, Civil Registration, Public Health England, and the UK Renal Registry (UKRR) in England, and equivalent databases in Scotland and Wales, as necessary – and centrally administered patient completed questionnaires. In addition, research personnel on-site will monitor for adverse events and collect data on adherence to the protocol (monthly during recruitment and quarterly during follow-up). Discussion This study will provide evidence of the effectiveness and cost effectiveness of HD as compared to HDF for adults with kidney failure in-centre HD or HDF. It will inform management for this patient group in the UK and internationally. Trial registration: ISRCTN10997319. Registered on 10th October 2017.

Systematic review to compare the outcomes associated with the modalities of expanded hemodialysis (HDx) versus high‐flux hemodialysis and/or hemodiafiltration (HDF) in patients with end‐stage kidney disease (ESKD)

“…84 The H4RT trial is a UK multicenter RCT of patients already undergoing HD or HDF and has a composite primary outcome of non-cancer mortality or hospital admission with a cardiovascular event or infection during follow-up. 85 It is challenging to make valid comparisons of the efficacy and safety of HDF versus HDx for several reasons. First, there is a paucity of long-term data available for HDx compared with the body of evidence available for HDF.…”