Therapeutic hypothermia in deceased kidney donors (hypothermia vs. machine perfusion)
Trial question
Is therapeutic hypothermia noninferior to machine perfusion of the kidney in brain-dead organ donors?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 869
869 patients (335 female, 534 male).
Inclusion criteria: adult brain-dead kidney donors.
Key exclusion criteria: donation after cardiac death; end-stage kidney disease; or a history of dialysis during terminal hospitalization.
Interventions
N=359 hypothermia (therapeutic hypothermia at 34-35 °C).
N=510 machine perfusion (ex situ kidney hypothermic machine perfusion).
Primary outcome
Delayed graft function in kidney transplant recipients
30%
19%
30.0 %
22.5 %
15.0 %
7.5 %
0.0 %
Hypothermia
Machine
perfusion
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in delayed graft function in kidney transplant recipients (30% vs. 19%; RR 1.72, 95% CI 1.35 to 2.17).
Conclusion
In adult brain-dead kidney donors, hypothermia was not noninferior to machine perfusion with respect to delayed graft function in kidney transplant recipients.
Reference
Darren Malinoski, Christina Saunders, Sharon Swain et al. Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med. 2023 Feb 2;388(5):418-426.
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