Normothermic Machine Perfusion (NMP) Versus Static Cold Storage (SCS) in Human Kidney Transplantation (NMP-DBD)
Kidney Transplant; Complications, Kidney Failure, Graft Dysfunction
About this trial
This is an interventional treatment trial for Kidney Transplant; Complications focused on measuring ex-vivo machine perfusion, normothermic machine perfusion, kidney transplantation, extended criteria donation, donation after brain death, NMP
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Patients 18 years or older
- Patients suffering from end-stage kidney disease / kidney failure
- Listed for kidney transplantation
- Receiving ECD-allograft
Exclusion Criteria:
- Recipients of living donor kidney transplants
- Previous kidney transplantation
- Combined transplantations (liver-kidney, kidney-pancreas, etc.)
- Participation in other kidney related trials
- Exposure to an investigational drug within 30 days prior to inclusion
- Unwilling or unable to follow the procedures outlined in the protocol
- Mentally or legally incapacitated
Sites / Locations
- Charité Universitaetsmedizin Berlin, Campus Mitte | Campus Virchow-KlinikumRecruiting
- Medizinische Hochschule Hannover (MHH), Department of Surgery and Transplantation
- University Hospital Heidelberg, Department of Surgery and Transplantation
- Ludwig-Maximilian's University, Campus Grosshadern, Department of General, Visceral, and Transplant Surgery
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Normothermic machine perfusion (NMP)
Statical cold storage (SCS)
End-ischemic NMP will be performed immediately after arrival of the allocated and static cold stored ECD kidney graft. The study protocol aims a duration of 4 hours. Machine perfusion will be performed with a combination of patient's blood group matched packed red blood cells (RBC) and a special manufactured solution with the currently only certified device in Europe (XVIVO - KidneyAssist®). After 4 hours of perfusion and viability assessment, the kidney allograft will be disconnected from the device immediately prior to transplantation and flushed with three litres of Custodiol HTK solution via the renal artery. Then transplantation will be performed in typical method.
Conventional method kidney transplantation of statical cold stored and transported ECD kidney allograft. The allocated kidney allograft will be flushed with Custodiol HTK solution during back table preparation with the aim of immediate implantation into recipient.