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- Title
Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial.
- Authors
Westphal, Glauco A.; Robinson, Caroline Cabral; Giordani, Natalia Elis; Teixeira, Cassiano; Rohden, Adriane Isabel; dos Passos Gimenes, Bruna; Guterres, Cátia Moreira; Madalena, Itiana Cardoso; Andrighetto, Luiza Vitelo; Souza da Silva, Sabrina; Barbosa da Silva, Daiana; Sganzerla, Daniel; Cavalcanti, Alexandre Biasi; Franke, Cristiano Augusto; Bozza, Fernando Augusto; Machado, Flávia Ribeiro; de Andrade, Joel; Pontes Azevedo, Luciano Cesar; Schneider, Silvana; Orlando, Bianca Rodrigues
- Abstract
This cluster randomized clinical trial evaluates the use of a clinical management checklist and incidence of cardiac arrest in brain-dead potential organ donors in Brazil. Key Points: Question: Compared with usual care, is an evidence-based checklist to guide clinical management effective in reducing cardiac arrest among brain-dead potential donors? Findings: In this cluster randomized trial of 1535 brain-dead potential donors from 63 hospitals, donor losses to cardiac arrest were not significantly lower in the intervention group than in the control group (9.4% vs 14.8%). In the intervention group with high adherence to the checklist, loss through cardiac arrest was significantly lower compared with the control group (5.3% vs 14.8%). Meaning: Findings of this study suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. Importance: The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. Objective: To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU). Design, Setting, and Participants: The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020. Interventions: Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care. Main Outcomes and Measures: The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group. Results: Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P =.11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P =.006). Conclusions and Relevance: 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. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. Trial Registration: ClinicalTrials.gov Identifier: NCT03179020
- Subjects
BRAZIL; EVALUATION of medical care; BRAIN death; INTENSIVE care units; RELATIVE medical risk; HOSPITALS; CONFIDENCE intervals; EVIDENCE-based medicine; HEALTH outcome assessment; RANDOMIZED controlled trials; CARDIAC arrest; DESCRIPTIVE statistics; RESEARCH funding; PATIENT care; STATISTICAL sampling; BRAIN injuries; DATA analysis software; GOAL (Psychology); ORGAN donation
- Publication
JAMA Network Open, 2023, Vol 6, Issue 12, pe2346901
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.46901