NCT03098706

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Organ Donor
• Brain Death
• Kidney Transplant; Complications
• Critical Illness
• Hypothermia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-08
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2017-04-04
• Last updated: 2022-06-21

Locations

54 sites across 1 country: France