Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

Kidney transplantation remains the only definitive treatment for end-stage renal disease, yet the increasing use of extended criteria donor (ECD) kidneys heightens the risk of ischemia-reperfusion injury, particularly under static cold storage (SCS). Continuous hypothermic machine perfusion (HMP) has been introduced to improve preservation quality, but robust clinical evidence regarding its predictive value for post-transplant outcomes in ECD kidneys after donation after brain death (DBD) is limited.

The PRE-MAP Kidney Study is a prospective, non-interventional, multicenter observational study conducted across all German transplant centers. The study systematically collects technical machine perfusion parameters (flow, resistance, perfusion duration) and correlates these with clinical outcomes following kidney transplantation.

The primary endpoint is 12-month kidney function (eGFR). Secondary endpoints include surgical complications, length of stay, and transplant-specific events (acute rejection, primary non-function, delayed graft function).

This national cohort aims to determine the prognostic significance of HMP parameters in marginal donor kidneys and to generate evidence supporting future recommendations for organ preservation and allocation practices.

Eligibility criteria

Qualifiers

Signed informed consent

Patients 18 years or older

Listed for kidney transplantation (KT)

Receiving ECD* donation after brain death kidney allografts following national organ procurement

Disqualifiers

Recipients of living donor KT

Combined transplantations (liver-kidney, kidney-pancreas, etc.)

Participation in another intervention-trial with interference of intervention and/or outcome of this study

Unwilling or unable to follow the procedures outlined in the protocol

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators