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COMPLETED
NCT03098706
NA

Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Trial" HYPOREME

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

532

Start Date

2017-11-08

Completion Date

2022-03-21

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

PROCEDURE

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

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.

Locations (54)

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