Therapeutic hypothermia in deceased organ donors and kidney-graft function

Claus U. Niemann, John Feiner, Sharon Swain, Scott Bunting, Melissa Friedman, Megan Crutchfield, Kristine Broglio, Ryutaro Hirose, John P. Roberts, Darren Malinoski

    Research output: Contribution to journalArticle

    109 Scopus citations

    Abstract

    BACKGROUND: Delayed graft function, which is reported in up to 50% of kidney-transplant recipients, is associated with increased costs and diminished long-term graft function. The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear. METHODS: We enrolled organ donors (after declaration of death according to neurologic criteria) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges: 34 to 35°C (hypothermia) or 36.5 to 37.5°C (normothermia). Temperature protocols, which were initiated after authorization was obtained for the organ to be donated and for the donor's participation in the study, ended when organ donors left the intensive care unit for organ recovery in the operating room. The primary outcome was delayed graft function in the kidney recipients, which was defined as the requirement for dialysis during the first week after transplantation. Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor. RESULTS: The study was terminated early, on the recommendation of an independent data and safety monitoring board, after the interim analysis showed efficacy of hypothermia. At trial termination, 370 organ donors had been enrolled (180 in the hypothermia group and 190 in the normothermia group). A total of 572 patients received a kidney transplant (285 kidneys from donors in the hypothermia group and 287 kidneys from donors in the normothermia group). Delayed graft function developed in 79 recipients of kidneys from donors in the hypothermia group (28%) and in 112 recipients of kidneys from donors in the normothermia group (39%) (odds ratio, 0.62; 95% confidence interval, 0.43 to 0.92; P = 0.02). CONCLUSIONS: Mild hypothermia, as compared with normothermia, in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients.

    Original languageEnglish (US)
    Pages (from-to)405-414
    Number of pages10
    JournalNew England Journal of Medicine
    Volume373
    Issue number5
    DOIs
    StatePublished - Jul 30 2015

      Fingerprint

    ASJC Scopus subject areas

    • Medicine(all)

    Cite this

    Niemann, C. U., Feiner, J., Swain, S., Bunting, S., Friedman, M., Crutchfield, M., Broglio, K., Hirose, R., Roberts, J. P., & Malinoski, D. (2015). Therapeutic hypothermia in deceased organ donors and kidney-graft function. New England Journal of Medicine, 373(5), 405-414. https://doi.org/10.1056/NEJMoa1501969