CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,427 enrolled
Drug / intervention
Pump Eligible - Normothermia - Pump Both Kidneys +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02525510
NCT02525510N/ACompleted

A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients

University of California, San Francisco·interventional·Posted Aug 17, 2015·Updated Jun 14, 2022

In Brief

A clinical study evaluating Pump Eligible - Normothermia - Pump Both Kidneys, Pump Eligible - Hypothermia and Pump Right Kidney, and 3 other interventions for Brain Death and 3 related conditions. Completed, enrolled 1,427 participants across 7 sites.

Detailed Summary

To protect kidney function during the transplantation process by comparing mild hypothermia in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney after recovery and prior to transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 17, 2015
Enrollment StartJul 26, 2017
Primary CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.9 years ago

Interventions

Pump Eligible - Normothermia - Pump Both Kidneysother

Normothermia and Machine Perfusion Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Recovered kidneys will receive machine perfusion prior to implantation.OPO's protocol

Pump Eligible - Hypothermia and Pump Right Kidneyother

Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Right Kidney will receive machine perfusion prior to implantation and the Left Kidney will receive cold storage. Recovered kidneys will be placed in University of Wisconsin for cold storage until reimplantation.

Pump Eligible - Hypothermia and Pump Left Kidneyother

Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Left Kidney will receive machine perfusion prior to implantation and the Right Kidney will receive cold storage.

Not Pump Eligible - Normothermiaother

Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Pulsatile Perfusion of kidney grafts based on the respective OPO's protocol

Not Pump Eligible - Hypothermiaother

Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.