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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; Grion, Cintia Magalhães Carvalho; Bezerra, Fernando Albuerne; Roman, Fernando Roberto; Leite, Francisco Olon; [...]

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

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  • Medientyp: E-Artikel
  • Titel: Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors : The DONORS Cluster Randomized Clinical Trial : The DONORS Cluster Randomized Clinical Trial
  • Beteiligte: 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; Grion, Cintia Magalhães Carvalho; Bezerra, Fernando Albuerne; Roman, Fernando Roberto; Leite, Francisco Olon; [...]
  • Erschienen: American Medical Association (AMA), 2023
  • Erschienen in: JAMA Network Open
  • Sprache: Englisch
  • DOI: 10.1001/jamanetworkopen.2023.46901
  • ISSN: 2574-3805
  • Schlagwörter: General Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Importance</jats:title><jats:p>The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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; <jats:italic>P</jats:italic> = .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; <jats:italic>P</jats:italic> = .006).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov/study/NCT03179020">NCT03179020</jats:ext-link></jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang