Therapeutic hypothermia in deceased kidney donors (hypothermia vs. hypothermia plus machine perfusion)

Trial question
Is hypothermia alone superior to a combination of hypothermia and machine perfusion 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 = 838
838 patients (317 female, 521 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 degree Celsius).
N=479 combination therapy (combination of therapeutic hypothermia and machine perfusion).
Primary outcome
Delayed graft function in kidney transplant recipients
30%
22%
30.0 %
22.5 %
15.0 %
7.5 %
0.0 %
Hypothermia
Combination therapy
Significant increase ▲
NNH = 12
Significant increase in delayed graft function in kidney transplant recipients (30% vs. 22%; RR 1.57, 95% CI 1.26 to 1.96).
Conclusion
In adult brain-dead kidney donors, hypothermia was inferior to combination therapy 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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