DONORS
Trial question
What is the effect of evidence-based, goal-directed checklist in brain-dead potential donors in the ICU?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 1535
1535 patients (626 female, 909 male).
Inclusion criteria: brain-dead potential donors in the ICU.
Key exclusion criteria: patients unsuitable for organ donation according to the criteria of Brazil's National Transplant System; hospitals with any clinical decision-making tools already in place.
Interventions
N=743 goal-directed evidence-based checklist (bedside use of a goal-directed evidence-based checklist to guide the management of potential brain-dead donors).
N=792 usual care (routine care without providing information about the checklist).
Primary outcome
Potential organ donors lost due to cardiac arrest
9.4%
14.8%
14.8 %
11.1 %
7.4 %
3.7 %
0.0 %
Goal-directed evidence-based
checklist
Usual
care
No significant
difference ↔
No significant difference in potential organ donors lost due to cardiac arrest (9.4% vs. 14.8%; RR 0.7, 95% CI 0.46 to 1.08).
Secondary outcomes
No significant difference in actual organ donors (44% vs. 41.2%; RR 1.04, 95% CI 0.87 to 1.26).
No significant difference in organs recovered per actual organ donor (2.8 units vs. 2.8 units; MD 0.05, 95% CI -0.15 to 0.25).
Significant decrease in potential organ donors lost due to cardiac arrest in those with adherence > 79.0% (5.3% vs. 14.8%; RR 0.41, 95% CI 0.22 to 0.78).
Conclusion
In brain-dead potential donors in the ICU, goal-directed evidence-based checklist was not superior to usual care with respect to potential organ donors lost due to cardiac arrest.
Reference
Glauco A Westphal, Caroline Cabral Robinson, Natalia Elis Giordani et al. Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2346901.
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