Dataset Information

Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol.

ABSTRACT:

Introduction

End-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.

Methods and analysis

This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years' follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.

Ethics and dissemination

The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.

Trial registration number

Netherlands National Trial Register (NTR 7138).

SUBMITTER: Blankestijn PJ

PROVIDER: S-EPMC7044930 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMore 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 h. 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.MethodsThis 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).DiscussionThis 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 registrationISRCTN10997319 . Registered on 10 October 2017.

Project description:BACKGROUND:Clinical practice guidelines regarding the use of high-flux haemodialysis membranes vary widely. OBJECTIVES:We aimed to analyse the current evidence reported for the benefits and harms of high-flux and low-flux haemodialysis. SEARCH METHODS:We searched Cochrane Renal Group's specialised register (July 2012), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1948 to March 2011), and EMBASE (1947 to March 2011) without language restriction. SELECTION CRITERIA:We included randomised controlled trials (RCTs) that compared high-flux haemodialysis with low-flux haemodialysis in people with end-stage kidney disease (ESKD) who required long-term haemodialysis. DATA COLLECTION AND ANALYSIS:Data were extracted independently by two authors for study characteristics (participants and interventions), risks of bias, and outcomes (all-cause mortality and cause-specific mortality, hospitalisation, health-related quality of life, carpal tunnel syndrome, dialysis-related arthropathy, kidney function, and symptoms) among people on haemodialysis. Treatment effects were expressed as a risk ratio (RR) or mean difference (MD), with 95% confidence intervals (CI) using the random-effects model. MAIN RESULTS:We included 33 studies that involved 3820 participants with ESKD. High-flux membranes reduced cardiovascular mortality (5 studies, 2612 participants: RR 0.83, 95% CI 0.70 to 0.99) but not all-cause mortality (10 studies, 2915 participants: RR 0.95, 95% CI 0.87 to 1.04) or infection-related mortality (3 studies, 2547 participants: RR 0.91, 95% CI 0.71 to 1.14). In absolute terms, high-flux membranes may prevent three cardiovascular deaths in 100 people treated with haemodialysis for two years. While high-flux membranes reduced predialysis beta-2 microglobulin levels (MD -12.17 mg/L, 95% CI -15.83 to -8.51 mg/L), insufficient data were available to reliably estimate the effects of membrane flux on hospitalisation, carpal tunnel syndrome, or amyloid-related arthropathy. Evidence for effects of high-flux membranes was limited by selective reporting in a few studies. Insufficient numbers of studies limited our ability to conduct subgroup analyses for membrane type, biocompatibility, or reuse. In general, the risk of bias was either high or unclear in the majority of studies. AUTHORS' CONCLUSIONS:High-flux haemodialysis may reduce cardiovascular mortality in people requiring haemodialysis by about 15%. A large well-designed RCT is now required to confirm this finding.