Hypothermia or Machine Perfusion in Kidney Donors

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

doi:10.1056/NEJMoa2118265

Hypothermia or Machine Perfusion in Kidney Donors

N Engl J Med. 2023 Feb 2;388(5):418-426. doi: 10.1056/NEJMoa2118265.

Affiliation

¹ From the Division of Trauma, Critical Care, and Acute Care Surgery, Oregon Health and Science University (D.M., T.G., R.N.), and the Pacific Northwest Transplant Bank (C.V.D.W.) - both in Portland; Berry Consultants, Austin (C.S., K.B.), LifeGift, Houston (P.R.W.), and South West Transplant Alliance, Dallas (J.R.) - all in Texas; Donor Alliance, Denver (J.P.); LifeSource, Minneapolis (K.K.); Donor Network Arizona, Tempe (P.J.G.); and Donor Network West, San Ramon (S.S.), and the Department of Anesthesia and Perioperative Care and the Department of Surgery, Division of Transplantation (C.U.N.), University of California, San Francisco - both in California.

PMID: 36724328
DOI: 10.1056/NEJMoa2118265

Abstract

Background: Therapeutic hypothermia in brain-dead organ donors has been shown to reduce delayed graft function in kidney recipients after transplantation. Data are needed on the effect of hypothermia as compared with machine perfusion on outcomes after kidney transplantation.

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: Among brain-dead organ donors, therapeutic hypothermia was inferior to machine perfusion of the kidney in reducing delayed graft function after transplantation. The combination of hypothermia and machine perfusion did not provide additional protection. (Funded by Arnold Ventures; ClinicalTrials.gov number, NCT02525510.).

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Brain Death
Delayed Graft Function / etiology
Delayed Graft Function / prevention & control
Graft Survival
Humans
Hypothermia*
Hypothermia, Induced* / adverse effects
Hypothermia, Induced* / methods
Kidney Transplantation* / adverse effects
Kidney Transplantation* / methods
Kidney* / surgery
Organ Preservation* / adverse effects
Organ Preservation* / methods
Perfusion* / adverse effects
Perfusion* / methods
Tissue Donors

Associated data

ClinicalTrials.gov/NCT02525510