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Therapeutic Hypothermia in Organ Donors

Follow-up and Safety Analysis

Malinoski, Darren MD1,2; Patel, Madhukar S. MD, MBA, ScM3; Axelrod, David A. MD, MBA4; Broglio, Kristine MS5; Lewis, Roger J. MD, PhD5,6,7; Groat, Tahnee MPH1; Niemann, Claus U. MD8,9

doi: 10.1097/TP.0000000000002890
Original Clinical Science–General
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Background. In a recent trial, targeted mild hypothermia in brain-dead organ donors significantly reduced the incidence of delayed graft function after kidney transplantation. This trial was stopped early for efficacy. Here, we report long-term graft survival for all organs along with donor critical care end points.

Methods. We assessed graft survival through 1 year of all solid organs transplanted from 370 donors who had been randomly assigned to hypothermia (34–35°C) or normothermia (36.5–37.5°C) before donation. Additionally, changes in standardized critical care end points were compared between donors in each group.

Results. Mild hypothermia was associated with a nonsignificant improvement in 1-year kidney transplant survival (95% versus 92%; hazard ratio, 0.61 [0.31–1.20]; P = 0.15). Mild hypothermia was associated with higher 1-year graft survival in the subgroup of standard criteria donors (97% versus 93%; hazard ratio, 0.39 [0.15 to −1.00]; P = 0.05). There were no significant differences in graft survival of extrarenal organs. There were no differences in critical care end points between groups.

Conclusions. Mild hypothermia in the donor safely reduced the rate of delayed graft function in kidney transplant recipients without adversely affecting donor physiology or extrarenal graft survival. Kidneys from standard criteria donors who received targeted mild hypothermia had improved 1-year graft survival.

1 Section of Surgical Critical Care, VA Portland Healthcare System, Portland, OR.

2 Division of Trauma, Critical Care, and Acute Care Surgery, Oregon Health and Science University, Portland, OR.

3 Department of Surgery, Massachusetts General Hospital, Boston, MA.

4 University of Iowa Transplant Institute, Iowa City, IA.

5 Berry Consultants, LLC, Austin, TX.

6 Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA.

7 Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA.

8 Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA.

9 Division of Transplantation, Department of Surgery, University of California San Francisco, CA.

Received 16 April 2019. Revision received 23 June 2019.

Accepted 12 July 2019.

The authors declare no conflicts of interest.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01680744.

This publication was supported by grant No. R38OT22183 (to C.U.N.) from the Health Resources and Services Administration (HRSA), US Department of Health and Human Services. The contents of this publication are solely the responsibility of the author(s) and do not necessarily represent the views of HRSA.

D.M. and C.U.N. contributed equally to the study. D.M. and C.U.N. participated in the study design. D.A.A. and T.G. participated in the data gathering. D.M., M.S.P., D.A.A., K.B., R.J.L., and C.U.N. participated in the data analysis. D.M., M.S.P., D.A.A., K.B., R.J.L., T.G., and C.U.N. participated in the data and analysis integrity and drafting or critical revision of manuscript. D.M. and C.U.N. were involved in the decision to publish.

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

Correspondence: Claus U. Niemann, MD, Department of Anesthesia and Perioperative Care, University of California at San Francisco, 521 Parnassus Ave, C 450, San Francisco, CA. (Claus.Niemann@ucsf.edu).

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