Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME)
Authors: Brulé Noëlle , Canet Emmanuel , Péré Morgane , Feuillet Fanny , Hourmant Maryvonne , Asehnoune Karim , Rozec Bertrand , Duveau Agnes , Dube Laurent , Pierrot Marc , Humbert Stanislas , Tirot Patrice , Boyer Jean-Marc , Martin-Lefevre Laurent , Labadie François , Robert René , Benard Thierry , Kerforne Thomas , Thierry Antoine , Lesieur Olivier , Vincent Jean-François , Lesouhaitier Mathieu , Larmet Raphaelle , Vigneau Cecile , Goepp Angelique , Bouju Pierre , Quentin Charlotte , Egreteau Pierre-Yves , Huet Olivier , Renault Anne , Le Meur Yannick , Venhard Jean-Christophe , Buchler Mathias , Michel Olivier , Voellmy Marie-Hélène , Herve Fabien , Schnell David , Courte Anne , Glotz Denis , Amrouche Lucile , Hazzan Marc , Kamar Nassim , Moal Valerie , Bourenne Jeremy , Le Quintrec-Donnette Moglie , Morelon Emmanuel , Boulain Thierry , Grimbert Philippe , Heng Anne Elisabeth , Merville Pierre , Garin Aude , Hiesse Christian , Fermier Brice , Mousson Christiane , Guyot-Colosio Charlotte , Bouvier Nicolas , Rerolle Jean-Philippe , Durrbach Antoine , Drouin Sarah , Caillard Sophie , Frimat Luc , Girerd Sophie , Albano Laetitia , Rostaing Lionel , Bertrand Dominique , Hertig Alexandre , Westeel Pierre-Francois , Montini Florent , Delpierre Eric , Dorez Dider , Alamartine Eric , Ouisse Carole , Sebille Veronique , Reignier Jean 
Published: March 2022

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.