Therapeutic Hypothermia in Organ Donors: Follow-up and Safety Analysis
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.
CET Conclusion
| Reviewer: | Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | This article reports a post-hoc analysis of recipients receiving organs from brain dead donors who had undergone either mild hypothermia (34-35°C) or normothermia (36.5-37.5°C). The primary analysis was previously published and the intervention was considered potentially practice changing (https://www.transplantlibrary.com/article/26222557). Targeted temperatures were achieved by using external cooling devices. Follow-up data of 565 kidney, 262 liver, 94 heart, 99 lung and 25 pancreas transplants were obtained from national registries. There were no statistically significant difference in the adjusted and unadjusted 1-year kidney graft survival rates, however a subgroup analysis by donor type showed that the graft survival rate was significantly higher in standard criteria donors undergoing hypothermia, also when adjusted for cold ischemia time. The 1-year adjusted and unadjusted graft survival rates for liver, heart, lung and pancreas transplants showed no statistically significant differences between the groups. |
Methodological quality
| Jadad score | 3 |
|---|---|
| Allocation concealment | NO |
| Data analysis | MODIFIED INTENTION TO TREAT |
Study Details
| Aims: | This study aimed to assess the impact and safety of the hypothermia protocol on the longer term graft survival of the kidney (targeted) and extra-renal (non-targeted) organs. |
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| Interventions: | This was a posthoc analysis of patients who had received organs from donors who were randomized to either hypothermia (34-35°C) or normothermia (36.5-37.5°C). |
| Participants: | 370 solid organ transplant donors from a previous trial. |
| Outcomes: | The outcome for this posthoc analysis was one-year graft survival for kidney transplants, the targeted organ of the intervention. |
| Follow Up: | 1 year |
Metadata
| Publication type: | Randomized Controlled Trial, Randomised Controlled Trial |
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| Organ: | Kidney; Pancreas; Liver; Simultaneous Kidney/Pancreas; Heart; Heart/Lung; Lung; Intestine; Various |
| Language: | Engish |
| MeSH terms: | Adult; Aged; Body Temperature; Brain Death; Delayed Graft Function; Follow-Up Studies; Graft Survival; Humans; Hypothermia, Induced; Kidney; Kidney Transplantation; Middle Aged; Patient Safety; Perfusion; Proportional Hazards Models; Tissue Donors; Tissue and Organ Procurement; Treatment Outcome; Pancreas Transplantation; Liver Transplantation; Heart Transplantation; Lung Transplantation; Heart-Lung Transplantation |