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. 2022 Mar 28;12(3):e052845.
doi: 10.1136/bmjopen-2021-052845.

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

Noëlle Brulé  1 , Emmanuel Canet  2 , Morgane Péré  3 , Fanny Feuillet  3   4 , Maryvonne Hourmant  5 , Karim Asehnoune  6 , Bertrand Rozec  7 , Agnes Duveau  8 , Laurent Dube  9 , Marc Pierrot  10 , Stanislas Humbert  11 , Patrice Tirot  12 , Jean-Marc Boyer  13 , Laurent Martin-Lefevre  14 , François Labadie  15 , René Robert  16   17 , Thierry Benard  18 , Thomas Kerforne  19 , Antoine Thierry  20 , Olivier Lesieur  21 , Jean-François Vincent  22 , Mathieu Lesouhaitier  23 , Raphaelle Larmet  24 , Cecile Vigneau  25 , Angelique Goepp  26 , Pierre Bouju  27 , Charlotte Quentin  28 , Pierre-Yves Egreteau  29 , Olivier Huet  30 , Anne Renault  31 , Yannick Le Meur  32 , Jean-Christophe Venhard  33 , Mathias Buchler  34 , Olivier Michel  35 , Marie-Hélène Voellmy  36 , Fabien Herve  37 , David Schnell  38 , Anne Courte  39 , Denis Glotz  40 , Lucile Amrouche  41 , Marc Hazzan  42 , Nassim Kamar  43 , Valerie Moal  44 , Jeremy Bourenne  45 , Moglie Le Quintrec-Donnette  46 , Emmanuel Morelon  47 , Thierry Boulain  48 , Philippe Grimbert  49 , Anne Elisabeth Heng  50 , Pierre Merville  51 , Aude Garin  52 , Christian Hiesse  53 , Brice Fermier  54 , Christiane Mousson  55 , Charlotte Guyot-Colosio  56 , Nicolas Bouvier  57 , Jean-Philippe Rerolle  58 , Antoine Durrbach  59 , Sarah Drouin  60 , Sophie Caillard  61 , Luc Frimat  62 , Sophie Girerd  63 , Laetitia Albano  64 , Lionel Rostaing  65 , Dominique Bertrand  66 , Alexandre Hertig  67 , Pierre-Francois Westeel  68 , Florent Montini  69 , Eric Delpierre  70 , Dider Dorez  71 , Eric Alamartine  72 , Carole Ouisse  73 , Veronique Sebille  3   4 , Jean Reignier  1
Affiliations

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

Noëlle Brulé et al. BMJ Open. .

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.

Keywords: dialysis; intensive & critical care; renal transplantation.

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Conflict of interest statement

Competing interests: EC received fees for lectures and conference talks and had travel and accommodation expenses related to attending scientific meetings covered by Gilead, Baxter and Sanofi-Genzyme.

Figures

Figure 1
Figure 1
Study flowchart. ECDs, expanded-criteria donors; RRT, renal replacement therapy.
See this image and copyright information in PMC

References

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