Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol
Authors
Blankestijn, Peter J.Fischer, Kathrin I.
Barth, Claudia
Cromm, Krister
Canaud, Bernard
Davenport, Andrew
Grobbee, Diederick E.
Hegbrant, Jorgen
Roes, Kit C.
Rose, Matthias S. F.
Strippoli, Giovanni Fm.
Vernooij, Robin Wm.
Woodward, Mark
de Wit, G. Ardine de
Bots, Michiel L.
UMass Chan Affiliations
Department of Quantitative Health SciencesDocument Type
Journal ArticlePublication Date
2020-02-05Keywords
end-stage kidney diseasehaemodiafiltration
haemodialysis
protocol
randomised controlled trial
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Female Urogenital Diseases and Pregnancy Complications
Health Services Administration
Health Services Research
Male Urogenital Diseases
Nephrology
Metadata
Show full item recordAbstract
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).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
DOI
10.1136/bmjopen-2019-033228Permanent Link to this Item
http://hdl.handle.net/20.500.14038/41369PubMed ID
32029487Related Resources
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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/.Distribution License
http://creativecommons.org/licenses/by-nc/4.0/ae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2019-033228
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Except where otherwise noted, this item's license is described as 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/.