Transplant Trial Watch

Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function.

Niemann CU, Feiner J, et al.

New England Journal of Medicine 2015; 373(5): 405-414.


Aims
To test the benefit of targeted hypothermia in organ donors before organ recovery on delayed graft function in kidney recipients.

Interventions
Deceased organ donors after declaration of death were randomised to undergo either hypothermia (34 to 35⁰C) or normothermia (36.5 to 37.5⁰C).

Participants
394 donors aged ≥ 18 years

Outcomes
The primary outcome measured was delayed graft function (the need for dialysis in the first week posttransplant). Secondary outcomes were the rate of individual organs transplanted in each treatment group and the number of organs transplanted from each enrolled donor.

Follow-up
1 week

CET Conclusions
This is a fascinating study with significant implications for preservation studies. The authors show that organ donors after brain death subjected to mild cooling had significantly less DGF than donors subjected to conventional normothermia before organ retrieval. In fact the DMC stopped the study on the basis that efficacy had been demonstrated before completion of recruitment. The effect was much more striking in expanded criteria donors. What does this mean in terms of ongoing trials of machine preservation after organ retrieval in kidney transplantation? Would the two approaches be complementary or would ongoing trials need to be repeated in organ donors who have been mildly cooled before retrieval of the kidneys? Certainly this study has provided food for thought in the preservation world!

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT01680744

Funding source
Non-industry funded