Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors
Reperfusion Injury, Hypothermic Oxygenated Machine Perfusion
About this trial
This is an interventional treatment trial for Reperfusion Injury focused on measuring Extended criteria donor, Donation after brain death, HOPE, Kidney transplantation
Eligibility Criteria
Inclusion Criteria:
Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.
ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension
Exclusion Criteria:
- Recipients of living donor kidney transplants
- Previous kidney transplantation
- Participation in other kidney related trials
- The subject received an investigational drug within 30 days prior to inclusion
- The subject is unwilling or unable to follow the procedures outlined in the protocol
- The subject is mentally or legally incapacitated
- Non-German or non-English speakers
- Family members of the investigators or employees of the participating department
- The subject is mentally or legally incapacitated
- The subject suffers from uncontrolled bacterial or viral infection
Sites / Locations
- Department of Surgery and Transplantation, University Hospital RWTH Aachen
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional cold storage
Hypothermic oxygenated perfusion (HOPE)
Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)
HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)