Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial
- Type de publi. : Article dans une revue
- Date de publi. : 01/09/2024
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Auteurs :
Emmanuel CanetNoëlle BruleMorgane PereFanny FeuilletGilles BlanchoLaurent Martin-LefevreClaire GarandeauKarim AsehnouneBertrand RozecAgnès DuveauLaurent DubeMarc PierrotStanislas HumbertPatrice TirotJean-Marc BoyerFrançois LabadieRené RobertThierry BenardT KerforneAntoine ThierryOlivier LesieurJean-François VincentMathieu LesouhaitierRaphaëlle LarmetCécile VigneauAngélique GoeppPierre BoujuCharlotte QuentinPierre-Yves EgreteauOlivier HuetAnne RenaultYannick Le MeurJean-Christophe VenhardMatthias BuchlerMarie-Hélène VoellmyFabien HerveDavid SchnellAnne CourteDenis GlotzLucile AmroucheMarc HazzanNassim KamarValérie MoalJérémy BourenneMoglie Le QuintrecMoglie Le QuintrecEmmanuel MorelonToufik KamelPhilippe GrimbertAnne-Elisabeth HengPierre MervilleAude GarinChristian HiesseBrice FermierChristiane MoussonCharlotte Guyot-ColosioNicolas BouvierJean-Philippe RerolleAntoine DurrbachSarah J. DrouinSophie CaillardLuc FrimatSophie GirerdLaetitia AlbanoLionel RostaingDominique BertrandAlexandre HertigPierre-François WesteelFlorent MontiniEric DelpierreDidier DorezEric AlamartineCarole OuisseVéronique SébilleJean Reignier
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Organismes :
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
methodS in Patients-centered outcomes and HEalth ResEarch
Team 3 : Integrative transplantation, HLA, Immunology and genomics of kidney injury
Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology
Team 6 : Impact of acute inflammation on host pathogen interactions and lung homeostasis
Service d'anesthésie et réanimation chirurgicale [Nantes]
Hôpital Guillaume-et-René-Laennec [CHU Nantes]
Centre Hospitalier Universitaire d'Angers
Centre Hospitalier Universitaire d'Angers
Université d'Angers
Centre Hospitalier de Cholet
Centre Hospitalier Le Mans (CH Le Mans)
Centre Hospitalier de Laval
Centre hospitalier de Saint-Nazaire
Laboratoire des Sciences de l'Environnement Marin (LEMAR)
Unité Littoral
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation »
Hôpitaux La Rochelle Ré Aunis [Groupe hospitalier littoral Atlantique]
Bibliothèque interuniversitaire de santé
Microenvironment and B-cells: Immunopathology, Cell Differentiation, and Cancer
Centre d'Investigation Clinique [Rennes]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Établissement Français du Sang Bretagne [Rennes]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Université de Rennes
Institut de recherche en santé, environnement et travail
CH Vannes
Groupe Hospitalier Bretagne Sud
CH de Saint-Malo [Broussais]
CH Morlaix
CHRU Brest - Département d'Anesthésie Réanimation
Optimisation des régulations physiologiques
Hôpital de la Cavale Blanche - CHRU Brest
CHRU Brest - Service de Nephrologie
Lymphocytes B, Autoimmunité et Immunothérapies
Centre Hospitalier Régional Universitaire de Tours
Service de néphrologie et immunologie clinique [CHRU Tours]
Centre Hospitalier Régional Universitaire de Tours
Membrane Signalling and Inflammation in reperfusion Injuries
Ecole Polytechnique de l'Université de Nantes
Centre Hospitalier d'Angoulême
Centre hospitalier Saint-Brieuc Paimpol Tréguier
Immunologie humaine, physiopathologie & immunothérapie
Hôpital Necker - Enfants Malades [AP-HP]
Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
Centre Hospitalier Régional Universitaire [Montpellier]
methodS in Patients-centered outcomes and HEalth ResEarch
- Publié dans The Lancet Respiratory Medicine le 23/10/2020
Résumé : Background - Expanded criteria donors help to increase graft availability, but provide organs with an increased risk of delayed graft function. We aimed to investigate whether donor hypothermia decreases the risk of delayed graft function compared with normothermia. Methods - We did this multicentre, randomised, controlled, parallel-arm trial at 53 intensive care units and transplant centres in France. We included expanded criteria donors in whom death was diagnosed based on neurological criteria, in compliance with French law, and the recipients of their kidney grafts. Eligible expanded criteria donors were older than 60 years or were aged 50-59 years and had at least two other risk factors (history of hypertension, creatinine >132 μmol/L, or cerebrovascular cause of death). Donors were randomly assigned to hypothermia (34-35°C) or normothermia (36·5-37·5°C). Machine perfusion was used routinely. Randomisation was done using a computer-generated, interactive, web-response system, in permuted blocks (block size six), stratified by centre. Outcome assessors were masked; investigator masking was not feasible. The primary outcome was the proportion of kidney recipients with delayed graft function, defined as renal replacement therapy within 7 days after transplantation, assessed in the modified intention-to-treat (mITT) population, which included all recipients who received at least one kidney from an expanded criteria donor, with the exception of those under guardianship. Secondary outcomes in expanded criteria donors were the number of organs recovered and transplanted, kidney function, body temperature, total volume of fluids administered, blood pressure and need for vasopressors and inotropes, and adverse events (cardiovascular events, metabolic disturbances, and coagulation disorders). Secondary outcomes in kidney recipients were duration of hospital stay, kidney graft function and vital status at day 7, day 28, 3 months, and 1 year after transplantation, and adverse events (infections, cardiovascular events, and surgical complications). Secondary outcomes were assessed in the mITT population. The trial was registered at ClinicalTrials.gov, NCT03098706. Findings - Between Nov 9, 2017, and March 3, 2021, 365 donors were randomly assigned, of whom 298 (151 [51%] male, 147 [49%] female) provided kidneys to 526 recipients (323 [61%] male, 203 [39%] female). 251 recipients in the hypothermia group and 275 recipients in the normothermia group were included in the analysis. Graft function was delayed in 40 (16%) of 251 recipients in the hypothermia group and 58 (21%) of 275 recipients in the normothermia group (odds ratio 0·71 [95% CI 0·44-1·13]; p=0·14; absolute difference -5·2% [95% CI 11·8-1·5]). Compared with donors in the normothermia group, donors in the hypothermia group had higher highest mean arterial pressure (115 mm Hg [SD 22] vs 108 mm Hg [20]; p=0·001). 1 year after transplantation, recipients in the hypothermia group had a lower mean creatinine concentration (152·4 μmol/L [SD 59·1] vs 169·7 μmol/L [51·4]; p=0·0351) and a higher mean creatinine clearance (42·3 mL/min/1·73 m [15·8] vs 40·5 mL/min/1·73 m [17·9]; p=0·0414) than those in the normothermia group. No significant differences between groups were identified for any other secondary outcomes. Interpretation - Hypothermia in expanded criteria donors whose organs were routinely stored using machine perfusion did not decrease the frequency of delayed kidney graft function. However, hypothermia was associated with a lower serum creatinine concentration and a higher creatinine clearance 1 year after transplantation. Funding - French Ministry of Health and French Intensive Care Society.
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