Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function

Julie Murphy, Mercer University College of Pharmacy

According to the National Kidney Foundation, the number of kidney transplants that occurred in 2014 equaled 17,105 with 11,570 of those donations coming from deceased donors.1 A study of therapeutic hypothermia in cardiac arrest patients suggests that mild hypothermia is renal protective.2 According to this author, normothermia is the proper protocol to maintain neurologically deceased organ donors.3

Title: Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function3
Design Randomized, prospective study; N= 302
Objective To determine the effect of mild hypothermic organ donors on the rate of delayed graft function
Study Groups Mild hypothermia (n= 150) and normothermia (n= 152)
Methods The mild hypothermia donors were cooled to the temperature range of 34ºC to 35ºC and normothermia donors were warmed to the 36.5ºC to 37.5ºC range.
Duration March 20, 2012, and October 17, 2013
Primary Outcome Measure The presence or absence of delayed graft function requiring for dialysis during the first week post-transplant
Baseline Characteristics
                   Organ Donor Baseline Characteristics
Hypothermia Normothermia P Value
Age 45±15 45±15 0.82
Male 62.7% 63.2%
Prior Hypothermia 12% 11.8% 1.0
Creatinine level at enrollment 1.1±0.6 1.1±0.6 0.62
Creatinine level last recorded in ICU 1.1±0.8 1.2±0.8 0.06
Glomerular filtration rate at enrollment 89.2±50.8 89.0±43.1 0.80
Glomerular filtration rate last recorded in ICU 103.4±58.1 88.2±43.9 0.03

Organ Recipient Baseline Characteristics

Hypothermia Normothermia P Value
Age 52.3±13.5 53.4±15.4 0.14
Male 61.8% 57.6%
Warm-ischemia time (min) 34±19 38±21 0.11
Cold-ischemia time (hr) 13.9±7.3 15.6±8.3 0.02
Results Hypothermia delayed graft function: 28.2%

Normothermia delayed graft function: 39.2%

P value 0.008

Adverse Events Common Adverse Events: N/A
Serious Adverse Events:

dysrhythmia and systemic hypertension in hypothermic donors

cardiac arrest in normothermia donors

Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Therapeutic hypothermia is statistically and clinically protective to kidney allographs

This Data and Safety Monitoring board ended this study early due to evidence of a 38% lower incidence of delayed graft function in the hypothermic group. The study also suggests that hypothermic treatment was particularly beneficial to high-risk subgroups such as older patients with comorbidities. The initial analysis indicates that delayed graft function was associated with the creatinine level at enrollment, age, and cold-ischemia time but the benefit of hypothermia was still found to be significant. Although this trial was not completely blinded, the authors felt that there was no bias because the bedside care providers and study investigators were blinded. It was suggested that the primary outcome assessment was properly blinded because the assessment was made in a different facility than the donor facility.3

References

  • Organ Donation and Transplantation Statistics. National Kidney Foundation. https://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats. Accessed August 7, 2015.
  • Wolfrum S, Pierau C, Radke PW, Schunkert H, Kurowski V. Mild therapeutic hypothermia in patients after out-of-hospital cardiac arrest due to acute ST-segment elevation myocardial infarction undergoing immediate percutaneous coronary intervention. Crit Care Med. 2008;36(6):1780-6.
  • Niemann CU, Feiner J, Swain S, et al. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015;373(5):405-14.
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