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

NCT03098706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2022-06-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098706 on ClinicalTrials.gov