Evidence-Based Checklist for Organ Donor Management – A Cluster-Randomized Trial

Abstract

Background: The effectiveness of evidence-based, goal-directed care to reduce losses of brain-dead potential organ donors through cardiac arrest is unclear. DONORS aimed to determine whether guiding clinical management with an evidence-based goal-directed checklist can reduce losses of potential organ donors to cardiac arrest. Methods: This open cluster randomized trial assigned adult intensive care units from hospitals across Brazil with 10 or more annual brain death reports to guide the management of potential donors with the checklist (intervention group) or to maintain usual care without the checklist (control group). Intervention group was instructed to apply a checklist with 13 clinical goals and 14 corresponding actions, every six hours, from study enrollment to organ retrieval. Consecutive potential donors between 14 and 90 years of age were included. Primary outcome was incidence of loss of brain-dead potential organ donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed checklist adherence as an effect modifier. Findings: Among 1771 potential donors screened, 1535 were included from 63 hospitals: 31 assigned to checklist guidance (743 potential donors) and 32 to usual care (792 potential donors). Seventy (9.4%) potential donors at intervention hospitals and 117 (14.8%) at control met the primary outcome (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.53 to 1.05; P=0.09). Median checklist adherence was 79% (interquartile range, 64% to 90%). Among those with adherence greater than 79%, primary outcome rate was lower than control group (5.3% vs. 14.8%; HR, 0.45; 9% CI, 0.26 to 0.75). Among those with low adherence, primary outcome rate was comparable to the control group. Interpretation: Overall use of the checklist in preventing donor loss due to cardiac arrest was inconclusive. However, predefined subgroup analysis suggests that high adherence to the checklist may reduce donor losses to cardiac arrest. Funding: Brazilian Ministry of Health through PROADI-SUS. Declaration of Interests: The authors have no conflicts of interest to disclose. Ethics Approval Statement: In accordance with ethical principles stated in the Resolution No. 466/2012 of the Brazilian National Health Council/Ministry of Health, the Research Ethics Committee of each participating hospital approved the conduct of this study with a waiver of consent for eligible potential donors. Trial Registration: ClinicalTrials.gov number, NCT03179020 (https://clinicaltrials.gov/ct2/show/NCT03179020)