Therapeutic hypothermia in deceased kidney donors (machine perfusion vs. machine perfusion plus hypothermia)
Trial question
Is combination of hypothermia and machine perfusion superior to machine perfusion alone of the kidney in brain-dead organ donors?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 989
989 patients (371 female, 618 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=479 combination therapy (combination of therapeutic hypothermia and machine perfusion).
N=510 machine perfusion (ex situ kidney hypothermic machine perfusion).
Primary outcome
Delayed graft function in kidney transplant recipients
22%
19%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Combination
therapy
Machine
perfusion
No significant
difference ↔
No significant difference in delayed graft function in kidney transplant recipients (22% vs. 19%; RR 1.09, 95% CI 0.85 to 1.4).
Conclusion
In adult brain-dead kidney donors, combination therapy was not superior 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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