Abstract | BACKGROUND: METHODS: At six organ-procurement facilities in the United States, we randomly assigned brain-dead kidney donors to undergo therapeutic hypothermia ( hypothermia group), ex situ kidney hypothermic machine perfusion (machine-perfusion group), or both (combination-therapy group). The primary outcome was delayed graft function in the kidney transplant recipients (defined as the initiation of dialysis during the first 7 days after transplantation). We also evaluated whether hypothermia alone was noninferior to machine perfusion alone and whether the combination of both methods was superior to each of the individual therapies. Secondary outcomes included graft survival at 1 year after transplantation. RESULTS: From 725 enrolled donors, 1349 kidneys were transplanted: 359 kidneys in the hypothermia group, 511 in the machine-perfusion group, and 479 in the combined-therapy group. Delayed graft function occurred in 109 patients (30%) in the hypothermia group, in 99 patients (19%) in the machine-perfusion group, and in 103 patients (22%) in the combination-therapy group. Adjusted risk ratios for delayed graft function were 1.72 (95% confidence interval [CI], 1.35 to 2.17) for hypothermia as compared with machine perfusion, 1.57 (95% CI, 1.26 to 1.96) for hypothermia as compared with combination therapy, and 1.09 (95% CI, 0.85 to 1.40) for combination therapy as compared with machine perfusion. At 1 year, the frequency of graft survival was similar in the three groups. A total of 10 adverse events were reported, including cardiovascular instability in 9 donors and organ loss in 1 donor owing to perfusion malfunction. CONCLUSIONS:
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Authors | Darren Malinoski, Christina Saunders, Sharon Swain, Tahnee Groat, Patrick R Wood, Jeffrey Reese, Rachel Nelson, Jennifer Prinz, Kate Kishish, Craig Van De Walker, P J Geraghty, Kristine Broglio, Claus U Niemann |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 388
Issue 5
Pg. 418-426
(02 02 2023)
ISSN: 1533-4406 [Electronic] United States |
PMID | 36724328
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2023 Massachusetts Medical Society. |
Topics |
- Humans
- Brain Death
- Delayed Graft Function
(etiology, prevention & control)
- Graft Survival
- Hypothermia
- Hypothermia, Induced
(adverse effects, methods)
- Kidney
(surgery)
- Kidney Transplantation
(adverse effects, methods)
- Organ Preservation
(adverse effects, methods)
- Perfusion
(adverse effects, methods)
- Tissue Donors
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