Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function
NCT ID: NCT03098706
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
532 participants
INTERVENTIONAL
2017-11-08
2022-03-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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NT normothermia
After 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.
Procedure control: normothermia
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.
HT mild hypothermia
The 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.
Procedure active
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.
Interventions
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Procedure control: normothermia
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.
Procedure active
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For transplant recipients : age 18 years or greater /information given and no opposition signed by recipients.
Exclusion Criteria
* For transplant recipients: age \<18 years / no information given and/or opposition signed by recipients.
50 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Amiens-Picardie
Amiens, , France
CHU d'Angers
Angers, , France
CH Angouleme
Angoulême, , France
CH Avignon
Avignon, , France
CH de Blois
Blois, , France
CHU de Bordeaux
Bordeaux, , France
CH Bourges
Bourges, , France
CHU Brest
Brest, , France
CHU Caen
Caen, , France
Ch Cholet
Cholet, , France
Chu Clermont Ferrand
Clermont-Ferrand, , France
Hopital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CH de Dreux
Dreux, , France
CHU Grenoble
Grenoble, , France
CH Marne la Vallée (GHEF)
Jossigny, , France
CH La Roche sur Yon
La Roche-sur-Yon, , France
CH La Rochelle
La Rochelle, , France
CH Laval
Laval, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
CH Lorient
Lorient, , France
CHU de Lyon
Lyon, , France
Hopital de la Conception
Marseille, , France
Hopital de la Timone
Marseille, , France
CH de Meaux (GHEF)
Meaux, , France
CHU Montpellier
Montpellier, , France
CH Morlaix
Morlaix, , France
Nantes University Hospital
Nantes, , France
CHU Nice
Nice, , France
CH Orléans
Orléans, , France
Hopital Saint Louis
Paris, , France
Hopital de la Pitié Salpetriere
Paris, , France
Hopital Necker
Paris, , France
CHU Tenon
Paris, , France
CHU Poitiers
Poitiers, , France
CH Annecy Genevois
Pringy, , France
CH Cornouaille
Quimper, , France
CHU Reims
Reims, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
CH Saint Brieuc
Saint-Brieuc, , France
CHRU Saint-Etienne
Saint-Etienne, , France
CH Saint Nazaire
Saint-Nazaire, , France
CH Saintes
Saintes, , France
CH Saint Malo
St-Malo, , France
CHU Strasbourg
Strasbourg, , France
CHU Foch
Suresnes, , France
CHU Toulouse
Toulouse, , France
CHU Tours
Tours, , France
CHRU Nancy
Vandœuvre-lès-Nancy, , France
CH Vannes
Vannes, , France
Countries
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References
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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.
Brule 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.
Other Identifiers
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RC16_0041
Identifier Type: -
Identifier Source: org_study_id
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