Article Text
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).
- haemodiafiltration
- haemodialysis
- end-stage kidney disease
- randomised controlled trial
- protocol
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Supplementary materials
Supplementary Data
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Footnotes
Correction notice The text has been corrected to "5-item sub-set of the General Self-Efficacy Scale by Schwarzer, R., & Jerusalem, M. (1995)"
Contributors PJB and MB conceived the study. PJB, KIF, CB, KC, BC, AD, DEG, JH, KR, MR, GFMS, RWMV, MW, AAW and MLB contributed to protocol development. PJB and MB drafted the protocol. PJB, KIF, CB, KC, BC, AD, DEG, JH, KR, MR, GFMS, RWMV, MW, AAW and MLB contributed to refinement of the study protocol and approved the final manuscript.
Funding This investigator-initiated project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 754803. The governance is given in online supplementary appendix 6.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.