Details

Autor(en) / 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, Jr, Francisco Olon
• Ferraz Siqueira, Íris Lima
• Oliveira, João Fernando Piccolo
• de Oliveira, Jr, Lúcio Couto
• de Melo, Maria de Fátima Rodrigues Buarque
• Leal, Patrícia Berg Gonçalves Pereira
• Diniz, Pedro Carvalho
• Moraes, Rafael Barbarena
• Salomão Pontes, Daniela Ferreira
• Araújo Queiroz, Josélio Emar
• Hammes, Luciano Serpa
• Meade, Maureen O
• Rosa, Regis Goulart
• Falavigna, Maicon

Titel

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

Ist Teil von

• JAMA network open, 2023-12, Vol.6 (12), p.e2346901-e2346901

Ort / Verlag

United States

Erscheinungsjahr

2023

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. 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). 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. 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. 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. 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). 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. ClinicalTrials.gov Identifier: NCT03179020.