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UNOS support cited in New England Journal of Medicine study

Modest body cooling of deceased kidney donors benefits early graft function

A team of researchers report in the July 30, 2015 edition of The New England Journal of Medicine that modest body cooling of kidney donors after declaration of brain death may significantly reduce the risk of delayed graft function (need for dialysis within a week after transplantation) in recipients. Reducing the risk of this complication can benefit longer-term kidney function and decrease costs associated with transplant treatment.

OPOs and transplant hospitals in UNOS Region 5 conducted the trial within the collaborative regional research infrastructure that has been developed over the past nine years. All eight OPOs in the region began collaborating in 2006 to develop a uniform checklist critical care endpoints, or donor management goals (DMGs), to guide the bedside care of organ donors after neurologic determination of death.

This collaboration has led to the creation of evidence-based practices where very few previously existed. It has also resulted in the creation of a web-based DMG data entry portal that is managed by UNOS and served as the primary database for the study. “UNOS’ support was essential to build trust in the transplant community by helping communicate with all stakeholders,” said Claus Niemann, M.D., the study’s lead author and professor of anesthesia and surgery at the University of California San Francisco Medical Center.

Darren Malinoski, M.D., the study’s co-principal investigator and senior author, is chief of the section of surgical care at the Portland VA Medical Center and associate professor of surgery at Oregon Health and Science University. He has led the data analysis of donor management practices that resulted in the development of the regional DMGs. While OPOs throughout the region utilize different individual clinical care protocols, prior studies have demonstrated that meeting the elements of the DMG checklist, also termed a “bundle,” is associated with increased organ utilization and improved kidney graft function in recipients. These prior studies, in turn, provided a framework upon which the interventional study reported in the journal was conducted.

Drs. Niemann and Malinoski both credited the leadership of Region 5 and the support of UNOS Regional Administrator Chrystal Graybill with establishing the infrastructure to allow the development of the guidelines and the large-scale trial. “UNOS helped tie it all together with complete transparency,” said Dr. Malinoski. “Perhaps even more than the findings of this study, it is a model of collaboration and accountability that can be replicated in future studies.”

The study involved 370 kidney donors from two organ procurement organizations serving portions of northern California, southern California and Nevada. After death was declared due to neurologic criteria and authorization was given for research, donors in the trial were randomly assigned to two groups. One group of donors was maintained at a normal range of body temperature (36.5 to 37.5 degrees Celsius); the other group was maintained at a slightly lower temperature (34 to 35 degrees Celsius). A total of 583 kidneys were transplanted from donors in the study.

Recipients of kidneys from the lower-temperature group of donors were 38 percent less likely to experience delayed graft function, a highly statistically significant finding. The benefit was greatest among recipients of expanded donor criteria kidneys (involving donors whose age or medical condition tend to result in shorter long-term kidney function). Because the results showed significant and positive results at an early stage, the study was terminated early by a Data and Safety Monitoring Board.

Ina Jochmans, M.D., Ph.D., and Christopher Watson, M.D., note in an accompanying editorial that the study’s results highlight the idea that “…in this era of high-technology medicine and targeted drug therapy, it is still possible to identify a simple, cheap intervention that can have dramatic therapeutic effects.”

For more detailed information, please read the article and editorial:

C. Niemann, J. Feiner, S. Swain, S. Bunting, M. Friedman, M. Crutchfield, K. Broglio, R. Hirose, J. Roberts, D. Malinoski. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. The New England Journal of Medicine, Vol. 373, No. 5, July 30, 2015, pp. 405-414.

I. Jochmans, C. Watson. Taking the Heat Out of Organ Donation. The New England Journal of Medicine, Vol. 373, No. 5, July 30, 2015, pp. 477-478.

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