Calcineurin Inhibitor in NEuRoloGically deceased donors to decrease kidney delayed graft function study: study protocol of the CINERGY Pilot randomised controlled trial.

Autor:	D'Aragon F; Department of Anesthesiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada frederick.daragon@usherbrooke.ca.; Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada., Selzner M; Multi-Organ Transplant Program, Toronto General Hospital, Toronto, Quebec, Canada.; Department of General Surgery, University of Toronto and Toronto General Hospital, University Health Network, Toronto, Ontario, Canada., Breau R; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada., Masse MH; Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada., Lamontagne F; Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.; Department of Medicine, Universite de Sherbrooke, Sherbrooke, Quebec, Canada., Masse M; Department of Medicine, Universite de Sherbrooke, Sherbrooke, Quebec, Canada., Chassé M; Department of Medicine, Université de Montréal, Montreal, Québec, Canada., Carrier FM; Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada., Cardinal H; Department of Medicine, Université de Montréal, Montreal, Québec, Canada., Chaudhury P; Department of Surgery and Oncology, McGill University, Montreal, Québec, Canada.; Transplant Québec, Montréal, Québec, Canada., Weiss M; Transplant Québec, Montreal, Québec, Canada.; Population Health and Optimal Health Practives Research Unit (Trauma - Emergency - Critical Care Medicine), Centre de Recherche du CHU de Québec - Université Laval, Quebec, Quebec, Canada., Lauzier F; Population Health and Optimal Health Practives Research Unit (Trauma - Emergency - Critical Care Medicine), Centre de Recherche du CHU de Québec - Université Laval, Quebec, Quebec, Canada.; Department of Medicine, Université Laval, Québec City, Québec, Canada.; Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada., Turgeon AF; Population Health and Optimal Health Practives Research Unit (Trauma - Emergency - Critical Care Medicine), Centre de Recherche du CHU de Québec - Université Laval, Quebec, Quebec, Canada.; Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada., Frenette AJ; Universite de Montreal, Montreal, Québec, Canada., Bolduc B; Department of Pharmacy, Centre integre universitaire de sante et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada., Ducharme A; Department of Medicine, Université de Montréal, Montreal, Québec, Canada.; Montreal Heart Institute, Montreal, Québec, Canada., Lamarche C; Department of Medicine, Université de Montréal, Montreal, Québec, Canada.; Hôpital Maisonneuve-Rosemont Research Institute, Montréal, Québec, Canada., Couture E; Department of Anesthesiology and Critical Care, Quebec Heart & Lung Institute, Université Laval, Quebec, Quebec, Canada., Holdsworth S; Canadian Donation and Transplant Research Program, Edmonton, Alberta, Canada., Bertholz L; Canadian Donation and Transplant Research Program, Edmonton, Alberta, Canada., Talbot H; Canadian Donation and Transplant Research Program, Edmonton, Alberta, Canada., Slessarev M; Department of Medicine, Division of Critical Care, Western University, London, Ontario, Canada., Luke P; Department of Surgery, Division of Urology, Western University, London, Ontario, Canada., Boyd JG; Department of Medicine, Division of Neurology, Queen's University, Kingston, Ontario, Canada.; Department of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada., Shamseddin MK; Department of Medicine, Division of Nephrology, Queen's University, Kingston, Ontario, Canada., Burns KEA; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.; Li Ka Shing Knowledge Institute, University Health Toronto - St. Michael's Hospital, Toronto, Ontario, Canada., Zaltzman J; Department of Medicine, University of Toronto, Toronto, Ontario, Canada., English S; Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada., Knoll G; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Department of Medicine, Division of Nephrology, University of Ottawa, Ottawa, Ontario, Canada., Dhanani S; Department of Pediatrics, Division of Critical Care, Children's Hospital of Eastern Ontario and University of Ottawa, Ottawa, Ontario, Canada., Healey A; Department of Medicine, Division of Emergency Medicine, McMaster University, Hamilton, Ontario, Canada., Hanna S; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada., Rochwerg B; Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Oczkowski SJW; Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Treleaven D; Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Meade M; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jun 13; Vol. 14 (6), pp. e086777. Date of Electronic Publication: 2024 Jun 13.
DOI:	10.1136/bmjopen-2024-086777
Abstrakt:	Introduction: Most solid organ transplants originate from donors meeting criteria for death by neurological criteria (DNC). Within the organ donor, physiological responses to brain death increase the risk of ischaemia reperfusion injury and delayed graft function. Donor preconditioning with calcineurin inhibition may reduce this risk. Methods and Analysis: We designed a multicentre placebo-controlled pilot randomised trial involving nine organ donation hospitals and all 28 transplant programmes in the Canadian provinces of Ontario and Québec. We planned to enrol 90 DNC donors and their approximately 324 organ recipients, totalling 414 participants. Donors receive an intravenous infusion of either tacrolimus 0.02 mg/kg over 4 hours prior to organ retrieval, or a matching placebo, while monitored in an intensive care unit for any haemodynamic changes during the infusion. Among all study organ recipients, we record measures of graft function for the first 7 days in hospital and we will record graft survival after 1 year. We examine the feasibility of this trial with respect to the proportion of all eligible donors enrolled and the proportion of all eligible transplant recipients consenting to receive a CINERGY organ transplant and to allow the use of their health data for study purposes. We will report these feasibility outcomes as proportions with 95% CIs. We also record any barriers encountered in the launch and in the implementation of this trial with detailed source documentation. Ethics and Dissemination: We will disseminate trial results through publications and presentations at participating sites and conferences. This study has been approved by Health Canada (HC6-24-c241083) and by the Research Ethics Boards of all participating sites and in Québec (MP-31-2020-3348) and Clinical Trials Ontario (Project #3309). Trial Registration Number: NCT05148715. Competing Interests: Competing interests: CL, FDA, FLam, FLau, F-MC and MC are recipients of research career awards from the Fonds de recherche du Québec-Santé. AFT is the chairholder of the Canada Research Chair in Critical Care Neurology and Trauma. FDA, MW and PC received stipends for their role at Transplant Québec MaS holds research grants from the Canadian Institute of Health Research and the New Frontiers in Research Fund related to organ donation research and received a stipend for his role as the Regional Medical Lead (Donation) from Ontario Health (Trillium Gift of Life Network). MSe, RB, M-HM, MMa, A-JF, BB, AD, EC, SHo, LB, HT, PL, JGB, MKS, KEAB, JZ, SE, GK, AH, SHa, BR, SJWO, DT and MMe declare no competing interests. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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