TY - JOUR
T1 - Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis
T2 - the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol
AU - Blankestijn, Peter J
AU - Fischer, Kathrin I
AU - Barth, Claudia
AU - Cromm, Krister
AU - Canaud, Bernard
AU - Davenport, Andrew
AU - Grobbee, Diederick E
AU - Hegbrant, Jörgen
AU - Roes, Kit C
AU - Rose, Matthias
AU - Strippoli, Giovanni Fm
AU - Vernooij, Robin Wm
AU - Woodward, Mark
AU - de Wit, G Ardine
AU - Bots, Michiel L
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/2/5
Y1 - 2020/2/5
N2 - 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).
AB - 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).
KW - end-stage kidney disease
KW - haemodiafiltration
KW - haemodialysis
KW - protocol
KW - randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85079083712&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-033228
DO - 10.1136/bmjopen-2019-033228
M3 - Article
C2 - 32029487
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e033228
ER -