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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Critical Illness; Organ Donor; Kidney Transplant; Complications; Hypothermia; Brain Death

Treatments: Procedure: Procedure control: normothermia; Procedure: Procedure active

Study type: Interventional

Funder types: Other

Identifiers

NCT03098706

RC16_0041

Details and patient eligibility

About

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.

Enrollment: 532 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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532 participants in 2 patient groups

NT normothermia

Other group

Description:

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.

Treatment:

Procedure: Procedure control: normothermia

HT mild hypothermia

Experimental group

Description:

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.

Treatment:

Procedure: Procedure active