Biomaterial Database

Hypothermia or Machine Perfusion in Kidney Donors. 2023

Darren Malinoski, and Christina Saunders, and Sharon Swain, and Tahnee Groat, and Patrick R Wood, and Jeffrey Reese, and Rachel Nelson, and Jennifer Prinz, and Kate Kishish, and Craig Van De Walker, and P J Geraghty, and Kristine Broglio, and Claus U Niemann

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.

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. 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. 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. 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.).

UI	MeSH Term	Description	Entries
D007035	Hypothermia	Lower than normal body temperature, especially in warm-blooded animals.	Hypothermia, Accidental,Accidental Hypothermia,Accidental Hypothermias,Hypothermias,Hypothermias, Accidental
D007036	Hypothermia, Induced	Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.	Induced Hypothermia,Mild Hypothermia, Induced,Moderate Hypothermia, Induced,Targeted Temperature Management,Therapeutic Hypothermia,Hypothermia, Therapeutic,Induced Mild Hypothermia,Induced Mild Hypothermias,Induced Moderate Hypothermia,Induced Moderate Hypothermias,Mild Hypothermias, Induced,Moderate Hypothermias, Induced,Targeted Temperature Managements
D007668	Kidney	Body organ that filters blood for the secretion of URINE and that regulates ion concentrations.	Kidneys
D009926	Organ Preservation	The process by which organs are kept viable outside of the organism from which they were removed (i.e., kept from decay by means of a chemical agent, cooling, or a fluid substitute that mimics the natural state within the organism).	Organ Preservations,Preservation, Organ,Preservations, Organ
D010477	Perfusion	Treatment process involving the injection of fluid into an organ or tissue.	Perfusions
D001926	Brain Death	A state of prolonged irreversible cessation of all brain activity, including lower brain stem function with the complete absence of voluntary movements, responses to stimuli, brain stem reflexes, and spontaneous respirations. Reversible conditions which mimic this clinical state (e.g., sedative overdose, hypothermia, etc.) are excluded prior to making the determination of brain death. (From Adams et al., Principles of Neurology, 6th ed, pp348-9)	Brain Dead,Coma Depasse,Irreversible Coma,Brain Deads,Coma, Irreversible,Death, Brain
D006085	Graft Survival	The survival of a graft in a host, the factors responsible for the survival and the changes occurring within the graft during growth in the host.	Graft Survivals,Survival, Graft,Survivals, Graft
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014019	Tissue Donors	Individuals supplying living tissue, organs, cells, blood or blood components for transfer or transplantation to histocompatible recipients.	Organ Donors,Donors,Ovum Donors,Semen Donors,Transplant Donors,Donor,Donor, Organ,Donor, Ovum,Donor, Semen,Donor, Tissue,Donor, Transplant,Donors, Organ,Donors, Ovum,Donors, Semen,Donors, Tissue,Donors, Transplant,Organ Donor,Ovum Donor,Semen Donor,Tissue Donor,Transplant Donor
D016030	Kidney Transplantation	The transference of a kidney from one human or animal to another.	Grafting, Kidney,Renal Transplantation,Transplantation, Kidney,Transplantation, Renal,Kidney Grafting,Kidney Transplantations,Renal Transplantations,Transplantations, Kidney,Transplantations, Renal