Neuroanesthesia & neurocritical care

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial

JAMA Netw OpenPublished Cluster randomised controlled trial

Primary resultResult — go to the resultRelative risk 0.70 95% CI 0.46–1.08

Authors' conclusion

This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest.

Study context

Population
Consecutive brain-dead potential donors aged 14 to 90 years in intensive care unit (ICUs) (≥10 brain deaths in previous 2 years) in Brazil
Participants
1,535 donors · 63 hospitals
Comparison
Evidence-based, goal-directed checklist vs usual care
  • Interventionn = 743
  • Controln = 792reference
Primary endpoint
Loss of brain-dead potential donors to cardiac arrest at the individual level
Methodological detailsopen-label, parallel-group, multicentre, Enrollment and follow-up June 20, 2017, to November 30, 2019
  • Open-label
  • Parallel-group
  • Multicentre
  • Enrollment and follow-up June 20, 2017, to November 30, 2019

Primary result

As reported in the abstract

Relative risk

0.70

95% CI 0.46–1.08

P = 0.11

Events by treatment group

Intervention vs Control
RR 0.70 (95% CI 0.46–1.08); P = 0.11

Further findings

OutcomeControlRR (95% CI)P value
Primary outcome, adherence >79.0% vs control (prespecified sensitivity analysis)14.8%0.41 (0.22–0.78)P = 0.006
  • Primary outcome, adherence >79.0% vs control (prespecified sensitivity analysis): Adherence >79.0% 5.3%

Original publication

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Netw Open. Published 1 December 2023. doi:10.1001/jamanetworkopen.2023.46901

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