Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol
Michiel L Bots,
Diederick E Grobbee,
Mark Woodward,
Peter J Blankestijn,
Andrew Davenport,
G Ardine de Wit,
Kit C Roes,
Kathrin I Fischer,
Claudia Barth,
Krister Cromm,
Bernard Canaud,
Jörgen Hegbrant,
Matthias Rose,
Giovanni FM Strippoli,
Robin WM Vernooij
Affiliations
Michiel L Bots
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Diederick E Grobbee
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Mark Woodward
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Peter J Blankestijn
Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands
Andrew Davenport
Department of Nephrology, University College of London, London, UK
G Ardine de Wit
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Kit C Roes
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
Kathrin I Fischer
Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin, Germany
Claudia Barth
B. Braun Avitum AG, Medical Scientific Affairs, Melsungen, Germany
Krister Cromm
Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg v.d.H, Germany
Bernard Canaud
Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg v.d.H, Germany
Jörgen Hegbrant
Department of Nephrology, Clinical Sciences, Lund University, Lund, Sweden
Matthias Rose
Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center of Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Berlin, Germany
Giovanni FM Strippoli
Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy
Robin WM Vernooij
Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands
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).
