6/28/23, 1:20 AM Deceased ODI to Protect KGF (hypothermia vs. machine perfusion) Pathway Feedback Search Clinical Topics Home Studies Deceased ODI to Protect KGF (hypothermia vs. machine perfusion) Deceased ODI to Protect KGF (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 38.0% female N = 869 62.0% male 869 patients (328 female, 542 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 30.0 % 30 22.5 % 19 15.0 % 7.5 % https://web.pathway.md/studies/recGN4tRyGHttShWn 1/2 6/28/23, 1:20 AM Deceased ODI to Protect KGF (hypothermia vs. machine perfusion) Pathway Difference exceeding nonferiority margin 0.0 % Hypothermia Machine perfusion Difference exceeding nonferiority 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. Open reference URL https://web.pathway.md/studies/recGN4tRyGHttShWn 2/2