Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function
HYPOREME
Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Trial" HYPOREME
1 other identifier
interventional
532
1 country
54
Brief Summary
Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage. The first is to increase the number of organs by developing harvesting from donors in a state of brain-death (BD) termed "expanded criteria donors" or from patients deceased from circulatory arrest. Another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (DFG). The development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in DGF reduction. Therapeutic Hypothermia could to be an attractive care strategy for BD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedJune 21, 2022
June 1, 2022
4.4 years
February 15, 2017
June 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
rate of patients with delayed graft function (DGF)
DGF is the recipient's requirement for dialysis during the first week after transplantation. To show the interest of Targeted Temperature Management in order to optimize the functional recovery of transplanted kidney transplants by comparing 2 groups of recipient subjects: those receiving one Graft from an "expanded criteria donors" maintained in hypothermia (34°-35°) and those receiving a graft from an "expanded criteria donors" maintained in normothermia (36,5°-37,5°).
Day 7
Secondary Outcomes (48)
Temperature Profile
24 hours
Severe arrhythmias
24 hours
Cardiac arrest
24 hours
Occurrence of hypotension measured by Total dose of inotropic drugs
24 hours
Occurrence of hypotension measured by cumulative fluid balance
24 hours
- +43 more secondary outcomes
Study Arms (2)
NT normothermia
OTHERAfter information for donation and research has been explained, organ donors in the normothermia (NT) group will either be maintained to spontaneously reach a body temperature of 36,5 °C-37,5°, until transfer to the operating room.
HT mild hypothermia
EXPERIMENTALThe intervention will take place after information for donation and research has been explained . Organ donors in the intervention group will either be actively warmed or allowed to reach a body temperature of 34 °C-35°C, until transfer to the operating room.
Interventions
Temperature will be maintained between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming will be introduce to maintain temperature between the range of 36.5 - 37.5°C.
Therapeutic hypothermia ie targeted controlled temperature between 34° and 35°C will be induced in the active group. Usual method of controlled temperature will be used in ICU: internal active method or external active method.
Eligibility Criteria
You may qualify if:
- For donors: legal determination of death by neurologic criteria/deceased organ donor/no medical contre-indication to donation/Information given to the authorizing surrogate/ Pregnant women.
- For transplant recipients : age 18 years or greater /information given and no opposition signed by recipients.
You may not qualify if:
- For donors: no legal determination of death by neurologic criteria/not a deceased organ donor/ medical contre-indication to donation/ no Information given to the authorizing surrogate.
- For transplant recipients: age \<18 years / no information given and/or opposition signed by recipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- Ministry of Health, Francecollaborator
Study Sites (54)
CHU Amiens-Picardie
Amiens, 80054, France
CHU d'Angers
Angers, 49000, France
CH Angouleme
Angoulême, 16959, France
CH Avignon
Avignon, 84000, France
CH de Blois
Blois, 41016, France
CHU de Bordeaux
Bordeaux, 33076, France
CH Bourges
Bourges, 18020, France
CHU Brest
Brest, 29200, France
CHU Caen
Caen, 14000, France
Ch Cholet
Cholet, 49325, France
Chu Clermont Ferrand
Clermont-Ferrand, France
Hopital Henri Mondor
Créteil, 94000, France
CHU de Dijon
Dijon, 21079, France
CH de Dreux
Dreux, 28100, France
CHU Grenoble
Grenoble, France
CH Marne la Vallée (GHEF)
Jossigny, 77600, France
CH La Roche sur Yon
La Roche-sur-Yon, 85925, France
CH La Rochelle
La Rochelle, 17019, France
CH Laval
Laval, 53000, France
Hopital Bicetre
Le Kremlin-Bicêtre, 94270, France
CH Le Mans
Le Mans, 72037, France
CHRU Lille
Lille, 59000, France
CHU Limoges
Limoges, 87042, France
CH Lorient
Lorient, 56322, France
CHU de Lyon
Lyon, France
Hopital de la Conception
Marseille, 13005, France
Hopital de la Timone
Marseille, 13005, France
CH de Meaux (GHEF)
Meaux, France
CHU Montpellier
Montpellier, France
CH Morlaix
Morlaix, 29672, France
Nantes University Hospital
Nantes, 44093, France
CHU Nice
Nice, 06000, France
CH Orléans
Orléans, 45067, France
Hopital Saint Louis
Paris, 75010, France
Hopital de la Pitié Salpetriere
Paris, 75013, France
Hopital Necker
Paris, 75015, France
CHU Tenon
Paris, 75020, France
CHU Poitiers
Poitiers, 86000, France
CH Annecy Genevois
Pringy, 74374, France
CH Cornouaille
Quimper, 29107, France
CHU Reims
Reims, 51100, France
CHU Rennes
Rennes, 35000, France
CHU Rouen
Rouen, 76000, France
CH Saint Brieuc
Saint-Brieuc, 22027, France
CHRU Saint-Etienne
Saint-Etienne, 42055, France
CH Saint Nazaire
Saint-Nazaire, 44606, France
CH Saintes
Saintes, 17108, France
CH Saint Malo
St-Malo, 35403, France
CHU Strasbourg
Strasbourg, 67091, France
CHU Foch
Suresnes, 92150, France
CHU Toulouse
Toulouse, 31403, France
CHU Tours
Tours, 37044, France
CHRU Nancy
Vandœuvre-lès-Nancy, 54511, France
CH Vannes
Vannes, 56000, France
Related Publications (2)
HYPOREME Trial Group. Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial. Lancet Respir Med. 2024 Sep;12(9):693-702. doi: 10.1016/S2213-2600(24)00117-6. Epub 2024 Jun 11.
PMID: 38876137DERIVEDBrule N, Canet E, Pere M, Feuillet F, Hourmant M, Asehnoune K, Rozec B, Duveau A, Dube L, Pierrot M, Humbert S, Tirot P, Boyer JM, Martin-Lefevre L, Labadie F, Robert R, Benard T, Kerforne T, Thierry A, Lesieur O, Vincent JF, Lesouhaitier M, Larmet R, Vigneau C, Goepp A, Bouju P, Quentin C, Egreteau PY, Huet O, Renault A, Le Meur Y, Venhard JC, Buchler M, Michel O, Voellmy MH, Herve F, Schnell D, Courte A, Glotz D, Amrouche L, Hazzan M, Kamar N, Moal V, Bourenne J, Le Quintrec-Donnette M, Morelon E, Boulain T, Grimbert P, Heng AE, Merville P, Garin A, Hiesse C, Fermier B, Mousson C, Guyot-Colosio C, Bouvier N, Rerolle JP, Durrbach A, Drouin S, Caillard S, Frimat L, Girerd S, Albano L, Rostaing L, Bertrand D, Hertig A, Westeel PF, Montini F, Delpierre E, Dorez D, Alamartine E, Ouisse C, Sebille V, Reignier J. Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME). BMJ Open. 2022 Mar 28;12(3):e052845. doi: 10.1136/bmjopen-2021-052845.
PMID: 35351701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
April 4, 2017
Study Start
November 8, 2017
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
June 21, 2022
Record last verified: 2022-06