Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors
Glauco Adrieno Westphal, Caroline Cabral Robinson, Natalia Elis Giordani, Cassiano Teixeira, Adriane Isabel Rohden, Bruna dos Passos Gimenes, Cátia Moreira Guterres, Itiana Cardoso Madalena, Luiza Vitelo Andrighetto, Sabrina Souza da Silva, Daiana Barbosa da Silva, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Cristiano Augusto Franke, Fernando A. Bozza, Flávia Ribeiro Machado, Joel de Andrade, Luciano César Pontes Azevedo, Silvana Schneider, Bianca Rodrigues Orlando, Cíntia Magalhães Carvalho Grion, Fernando Albuerne Bezerra, Fernando Roberto Roman, Francisco Olon Leite, Íris Lima Ferraz Siqueira, João Fernando Piccolo Oliveira, Lúcio Couto de Oliveira, Maria de Fátima Rodrigues Buarque de Melo, Patrícia Berg Gonçalves Pereira Leal, Pedro Carvalho Diniz, Rafael Barbarena de Moraes, Daniela Ferreira Salomão Pontes, Josélio Emar Araújo Queiroz, Luciano Serpa Hammes, Maureen O. Meade, Régis Goulart Rosa, Maicon Falavigna, Laercio M de Stefano, Marina CA Cleto, Aline R Zambrini, Cintia Banin, Maria OG Douglas, Renato Luis Borba, Daniela Boni, Eliza MP Monteiro, Airton L. O. Manoel, Ciro Parioto Neto, Wilson José Lovato, Rodrigo Barbosa Cerantola, Leonardo Carvalho Palma, Salomón Ordinola Rojas, Viviane Cordeiro Veiga, Luciana S Freitas, Roberto de Marco, F Hirata, Cinthia C Vieira, M Jackiu, Alessandra Duarte Santiago, M. Bertin, Luiz Otsubo, Ana L P Marques, Josileide F de Almeida, Martha P Torres, Gileade G dos Santos, Márcia C Gomes, Caio L S Nunes, Felipe A Moreira, Daniele S M V Simões, Leonardo d S Reis, Mariane S L de Souza, Rismaria M R de Castro, Valeska M N Gameiro, Regiane C Ferrari, Daniela B Ramos, Leny N. M. Passos, América C B M Sodré, Rita C M P Pedrosa, Eliana Régia Barbosa de Almeida, Camila Hirata, Raquel DC Matiello, Maria S Machado, F. Castro, Gustavo Pires Gonçalves, Maria I G de Oliveira, Omar Lopes Cançado, Claire C Miozzo, Gyanna L M M Montenegro, Noemy A C Gomes, Arlene Terezinha Cagol Garcia Badoch, Rodrigo Sarlo, Gabriel T M Pereira, Raissa M Marques, Suely L A Toledo, Ricardo K Ruhling, Benito O Fernandez, Agenor Spalini, Francisco A S Monteiro, Marizete P Medeiros, Caroline Longaray de Oliveira, Gabriela Soares Rech
Abstract
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.