NCT03098706: HYPOREME

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

Completed NA Last updated 21 June 2022

What this trial tests

NA trial testing Procedure control: normothermia in Organ Donor in 532 participants. Completed in 21 March 2022.

Timeline

8 November 2017

Primary endpoint
21 March 2022

21 March 2022

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	532
Start date	8 November 2017
Primary completion	21 March 2022
Estimated completion	21 March 2022
Sites	54 locations across France

Drugs / interventions tested

• Procedure control: normothermia
• Procedure active

Conditions studied

• Organ Donor — all drugs for Organ Donor →
• Brain Death — all drugs for Brain Death →
• Kidney Transplant; Complications — all drugs for Kidney Transplant; Complications →
• Critical Illness — all drugs for Critical Illness →

Sponsor

Nantes University Hospital

Who can join

50 and older, any sex, with Organ Donor or Brain Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mild Therapeutic Hypothermia Protects from Acute and Chronic Renal Ischemia-Reperfusion Injury in Mice by Mitigated Mitochondrial Dysfunction and Modulation of Local and Systemic Inflammation.
   Schleef M, Gonnot F, Pillot B, Leon C, et al · · 2022 · cited 15× · PMID 36012493 · DOI 10.3390/ijms23169229
2. Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial.
   HYPOREME Trial Group. · · 2024 · cited 7× · PMID 38876137 · DOI 10.1016/s2213-2600(24)00117-6
3. Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME).
   Brulé N, Canet E, Péré M, Feuillet F, et al · · 2022 · cited 3× · PMID 35351701 · DOI 10.1136/bmjopen-2021-052845
4. Transplant Trial Watch.
   O'Callaghan JM, Knight S, Mentor K. · · 2024 · PMID 39403303 · DOI 10.3389/ti.2024.13746