Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial.Rijkse, E., et al.
International Journal of Surgery Protocols 2021; 25(1): 227-237.
This study aims to compare the efficacy of 120 minutes of additional, end-ischemic normothermic machine perfusion (NMP) versus hypothermic machine perfusion (HMP) alone on immediate graft function following expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) kidney transplantation.
Participants will be randomised to either the NMP group or the HMP group.
Kidney transplant patients who receive an ECD-DBD or DCD Maastricht type III-V kidney.
The primary outcome is immediate graft function.
This manuscript describes the protocol for a novel study comparing end-ischaemic normothermic machine preservation (NMP) for 120 minutes to continuation of hypothermic machine preservation (HMP) until transplantation. The study will recruit recipients of DCD and ECD-DBD kidneys. Primary endpoint is immediate graft function, defined by absence of dialysis in the first week post-transplant. The protocol is well written and clearly described. Use of immediate function as the primary endpoint does have the issue of limiting recruitment to patients established on dialysis; use of a functional definition would have allowed broader recruitment. A notably absent secondary endpoint is the rate of organ discard between the two groups – utilisation would be an important efficacy and safety outcome in a study of this nature.
ClinicalTrials.gov - NCT04882254