UMMS Affiliation

Department of Quantitative Health Sciences

Publication Date

2020-02-05

Document Type

Article

Disciplines

Analytical, Diagnostic and Therapeutic Techniques and Equipment | Female Urogenital Diseases and Pregnancy Complications | Health Services Administration | Health Services Research | Male Urogenital Diseases | Nephrology

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).

Keywords

end-stage kidney disease, haemodiafiltration, haemodialysis, protocol, randomised controlled trial

Rights and Permissions

Copyright © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. 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/.

DOI of Published Version

10.1136/bmjopen-2019-033228

Source

Blankestijn PJ, Fischer KI, Barth C, Cromm K, Canaud B, Davenport A, Grobbee DE, Hegbrant J, Roes KC, Rose M, Strippoli GF, Vernooij RW, Woodward M, de Wit GA de, Bots ML. Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol. BMJ Open. 2020 Feb 5;10(2):e033228. doi: 10.1136/bmjopen-2019-033228. PMID: 32029487; PMCID: PMC7044930. Link to article on publisher's site

Journal/Book/Conference Title

BMJ open

Related Resources

Link to Article in PubMed

PubMed ID

32029487

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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