6/28/23, 1:20 AM Deceased ODI to Protect KGF (hypothermia vs. hypothermia plus machine perfusion) Pathway Feedback Search Clinical Topics Deceased ODI to Protect KGF (hypothermia vs. hypothermia plus machine perfusion) Home Studies Deceased ODI to Protect KGF (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 N = 838 62.0% male 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 30.0 % 30 22.5 % 22 15.0 % 7.5 % https://web.pathway.md/studies/rec36Zt0cjsEXcYnI 1/2 6/28/23, 1:20 AM 5 % Deceased ODI to Protect KGF (hypothermia vs. hypothermia plus machine perfusion) Pathway Borderline significant increase 0.0 % Hypothermia Combination therapy Borderline 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 not superior 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. Open reference URL https://web.pathway.md/studies/rec36Zt0cjsEXcYnI 2/2