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

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Renal medicine
Protocol
Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol
  1. Peter J Blankestijn1,
  2. Kathrin I Fischer2,
  3. Claudia Barth3,
  4. Krister Cromm4,
  5. Bernard Canaud4,5,
  6. Andrew Davenport6,
  7. Diederick E Grobbee7,8,
  8. Jörgen Hegbrant9,
  9. Kit C Roes7,
  10. Matthias Rose2,10,
  11. Giovanni FM Strippoli11,12,
  12. Robin WM Vernooij1,7,
  13. Mark Woodward13,14,15,
  14. G Ardine de Wit7,16,
  15. Michiel L Bots7
  1. 1Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands
  2. 2Charité 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
  3. 3B. Braun Avitum AG, Medical Scientific Affairs, Melsungen, Germany
  4. 4Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg v.d.H, Germany
  5. 5Montpellier University, School of Medicine, Montpellier, France
  6. 6Department of Nephrology, University College of London, London, UK
  7. 7Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
  8. 8Julius Clinical, Academic Clinical Research Organisation, Zeist, The Netherlands
  9. 9Department of Nephrology, Clinical Sciences, Lund University, Lund, Sweden
  10. 10Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA
  11. 11Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy
  12. 12University of Sydney, School of Public Health, Sydney, New South Wales, Australia
  13. 13The George Institute for Global Health, University of Oxford, Oxford, UK
  14. 14The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
  15. 15Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA
  16. 16Centre for Nutrition, Prevention and Health Services, National Institute of Public Health and the Environment, Bilthoven, The Netherlands
  1. Correspondence to Dr Peter J Blankestijn; P.J.Blankestijn{at}umcutrecht.nl

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
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-033228

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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.