Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME).

Abstract

INTRODUCTION:

Expanded-criteria donors (ECDs) are used to reduce the shortage of kidneys for transplantation. However, kidneys from ECDs are associated with an increased risk of delayed graft function (DGF), a risk factor for allograft loss and mortality. HYPOREME will be a multicentre randomised controlled trial (RCT) comparing targeted hypothermia to normothermia in ECDs, in a country where the use of machine perfusion for organ storage is the standard of care. We hypothesise that hypothermia will decrease the incidence of DGF.

METHODS AND ANALYSIS:

HYPOREME is a multicentre RCT comparing the effect on kidney function in recipients of targeted hypothermia (34°C-35°C) and normothermia (36.5°C-37.5°C) in the ECDs. The temperature intervention starts from randomisation and is maintained until aortic clamping in the operating room. We aim to enrol 289 ECDs in order to analyse the kidney function of 516 recipients in the 53 participating centres. The primary outcome is the occurrence of DGF in kidney recipients, defined as a requirement for renal replacement therapy within 7 days after transplantation (not counting a single session for hyperkalemia during the first 24 hours). Secondary outcomes include the proportion of patients with individual organs transplanted in each group; the number of organs transplanted from each ECD and the vital status and kidney function of the recipients 7 days, 28 days, 3 months and 1 year after transplantation. An interim analysis is planned after the enrolment of 258 kidney recipients.

ETHICS AND DISSEMINATION:

The trial was approved by the ethics committee of the French Intensive Care Society (CE-SRLF-16-07) on 26 April 2016 and by the competent French authorities on 20 April 2016 (Comité de Protection des Personnes-TOURS-Région Centre-Ouest 1, registration #2016-S3). Findings will be published in peer-reviewed journals and presented during national and international scientific meetings.

TRIAL REGISTRATION NUMBER:

NCT03098706.

• Authors: Noëlle Brulé, Emmanuel Canet, Morgane Péré, Fanny Feuillet, Maryvonne Hourmant, Karim Asehnoune, Bertrand Rozec, Agnes Duveau, Laurent Dube, Marc Pierrot, Stanislas Humbert, Patrice Tirot, Jean-Marc Boyer, Laurent Martin-Lefevre, François Labadie, René Robert, Thierry Benard, Thomas Kerforne, Antoine Thierry, Olivier Lesieur, Jean-François Vincent, Mathieu Lesouhaitier, Raphaelle Larmet, Cecile Vigneau, Angelique Goepp, Pierre Bouju, Charlotte Quentin, Pierre-Yves Egreteau, Olivier Huet, Anne Renault, Yannick Le Meur, Jean-Christophe Venhard, Mathias Buchler, Olivier Michel, Marie-Hélène Voellmy, Fabien Herve, David Schnell, Anne Courte, Denis Glotz, Lucile Amrouche, Marc Hazzan, Nassim Kamar, Valerie Moal, Jeremy Bourenne, Moglie Le Quintrec-Donnette, Emmanuel Morelon, Thierry Boulain, Philippe Grimbert, Anne Elisabeth Heng, Pierre Merville, Aude Garin, Christian Hiesse, Brice Fermier, Christiane Mousson, Charlotte Guyot-Colosio, Nicolas Bouvier, Jean-Philippe Rerolle, Antoine Durrbach, Sarah Drouin, Sophie Caillard, Luc Frimat, Sophie Girerd, Laetitia Albano, Lionel Rostaing, Dominique Bertrand, Alexandre Hertig, Pierre-Francois Westeel, Florent Montini, Eric Delpierre, Dider Dorez, Eric Alamartine, Carole Ouisse, Veronique Sebille, Jean Reignier
• Journal: BMJ open (BMJ Open) Vol. 12 Issue 3 Pg. e052845 (03 28 2022) ISSN: 2044-6055 [Electronic] England
• PMID: 35351701 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Topics

• Graft Survival
• Humans
• Hypothermia (etiology)
• Kidney
• Kidney Transplantation (adverse effects)
• Multicenter Studies as Topic
• Randomized Controlled Trials as Topic
• Tissue Donors
• Transplants