Author
Affilliation
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.
Publisher
American Medical Association
Citation
WESTPHAL, Glauco A. et al. Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Network Open, v. 6, n. 12, p. 1-14, Dec. 2023.
DOI
10.1001/jamanetworkopen.2023.46901
ISSN
2574-3805
Notes
Collaborators: DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network): Laercio M. de Stefano, Marina Ca Cleto, Aline R. Zambrini, Cintia Banin, Maria Og Douglas, Renato L. Borba, Daniela Boni, Eliza Mp Monteiro, Airton Lo Manoel, Ciro Parioto Neto, Wilson J. Lovato, Rodrigo B. Cerantola, Leonardo C. Palma, Salomon O. Rojas, Viviane C. Veiga, Luciana S. Freitas, Roberto Marco, Fabiano Hirata, Cinthia C. Vieira, Miriam Jackiu, Alessandra D. Santiago, Márcia R. 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 R. B. de Almeida, Camila Hirata, Raquel Dc Matiello, Maria S. Machado, Fernando Castro, Gustavo P. Gonçalves, Maria I. G. de Oliveira, Omar L. Cançado Jr, Claire C. Miozzo, Gyanna L. M. M. Montenegro, Noemy A. C. Gomes, Arlene T. C. G. Badoch, Rodrigo A. 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 L. de Oliveira, Gabriela S. Rech, Patrícia S. Benck, Silvana R. Tomé, Silvia Em de Mendonça, Vitor A. Wecki, Miriam Mv Machado, Carmen Segovia, Aline Ghellere, Charlene V. da Silva, Dagoberto F. da Rocha, Eduardo Berbigier, Edvaldo Leal, Felipe Pfuetzenreifer, Fernando Bourscheit, José L. Toribio, Luana Tannous, Luana Heberle, Neide Knihs, Paulo Rc Cardoso, Marcelo Grando, Ludmylla Bv Veras, Gigliane Ma Albuquerque, Régis A Hashimoto, Mateus Rt Teles, Rosely B. Cruz, Nelson Ac Pinheiro Jr, Janapina Mmf de Moraes, Claudete M. Balzan, Lúcia Ra Leite, Lis Dp Oliveira, Thattyane B. Pereira, Edwin F. Novillo, Maxwendell G. Batista, Silvecler C. de Campos, Marcelo S. Ferreira, Helen Ca Bezerra, Paulo Hl Matos, Janaína Feijó, Dernivania A. Ferreira, Ana Prb Machado, Poliana N. Santos, Felipe Fr de Souza, Daniela C. de Oliveira, Graças M. Dias Reis, Ana V. Rolim, Samira R. Magalhães, Cleiriane Reis, Joel I. Costa, Larissa Sp Carneiro, Márcia Mvs Passos, Gustavo M. Dos Santos, José Wb de Souza, Bruna Bo Marinho, Luiz Dp Salles Jr, José H. Gurgel, Iranildo P. Fontenele, Layanny Tl Bezerra, Cristiano A. Costa, Israel F. da Costa, Diego Bs Pinheiro, Denise M. de Moura, Suzana Cantidio, Jéssica Psl Moreira, Telma A. Belém, Symoni Bfq Florentino, Bruna S. Carvalho, Ciro L. Mendes, Igor M. do Nascimento, Paloma E. Araújo, Maryjane Ao Araújo, Alexandre Ag Alves, Heloisa Rfo Lima, Silvia Hca Carvalho, Clayton Aragão, Marko Af Santos, Luiza Mn Moraes, Henrique Lcn Sobrinho, Sylvia Hal Siqueira, Janaína R. Silva, Samyra P. Moraes, Janaína Cw Carvalho, Luiz H. Silva, Viviane M. Silva, Jander P. Fornaciari, Ana Pn Curty, Ivens G. Soares, Caroline S. Pimentel, Marco Am Castilho Jr, Tânia Laa Veiga, Frederico B. Carvalho, Natasha P. Ferreira, Sylmara Jz Freitas, Fernanda Cp Sousa, Chen Laura, Vandack A. Nobre Jr, Christiane Fmhm Pereira, Amélia C. Gomes, Jeová F. Oliveira, Paula G. Nasser, Alexandre S. Ferreira, Mara R Moura, Claudio D. Oliveira, Andressa S. Moreira, Raquel B. Santiago, Marina F. Oliveira, Ana Os Neves, Rodrigo Cg Silva, Roberto Almeida, Karin A. Zili, Alexsandro Js Fernandes, Ana L. Mezzaroba, Josiane Festti, Alexandre S. Larangeira, Thomas M. Dhaese, Simone Macedo Hanke, Guilherme Arcaro, Pericles Ad Duarte, Elaine F. Padilha, Cleber Tchaicka, Lizandra O. Ayres, Marcos T. Tanita, Carlos A. Oliveira, Almir Germano, Catia M. Dell Agnolo, Rosane A. Freitas, Ellen S. Barbosa, Vanessa M. Mezzavila, Renata Santos, Pedro Rigon Jr, Itamar Weiwanko, Cristiano Mroginski, Waldir A. Pasa Jr, Maikel Ramthun, Jullye C. Pereira, César Ab Flores, Patrícia B. Cwiertnia, Ricardo Gz Risson, Joseane A. Taborda, Mayara F. Vieira, Tatiana E. Cassolli, Mariana P. Singer, Rosiane O. Pereira, Jaciara R. Oliveira, Melina As Lemos, Vivianne Cb Toniol, Mariza A. Souza, Ângelo Y. Hayashi, Priscila Ll Paula, Elza de Lara Bezerra, Fernanda Gz Borges, Elaine S. Ramos, Cibele A. Marochi, Jessyca Braga, Alexander O. Sodré, Letícia Ap Entrago, Thiago M. Barcelos, Roberta C. de Jesus, Vitor M. Vianna, Mônica Sfs de Melo, Tais Cb Vaz, Flávio E. Santos, Vladimir S. Begni, Fábio F. Cardoso, Lucas Mallmann, Adriana Calvi, Nelson B. Franco Neto, Angélica Oliveira, Flávio Ac Alves, Manoel No Silveira, Deisi Lo da Fonseca, Susana Santini, Edison M. Rodrigues Filho, Fernanda P. Bonow, Ruth Susin, Kellen Pm Machado, Danielle M. de Aguiar, Caroline S. Scheneider, Lidiane C. Braz, Carlos Fp do Bem, Tatiana H. Rech, Vivian W. de Aquino, Luciano O. Teixeira, Viviane A. Mendonça, Silvia Z. Bizarro, José O. Calvete, Lina Maito, Sabrina F. Henrich, Larissa A. PeLlizzaro, Giovana C. Mecatti, Thiago C. Filiponi, Felipe Fp Barbosa, Flávia Gozzoli, André S. Ribeiro, Paulo Hp Rosateli, Zeher M Waked, Ana P. Quintal, Suzana Ma Lobo, Regiane Sampaio, Marcos Morais, James L. Rol, Bianca R. Orlando, Cintia Mc Grion, Fernando A. Bezerra, Fernando R. Roman, Francisco O. Leite Jr, Íris Lf Siqueira, João Fp Oliveira, Lucio C. de Oliveira Jr, Maria Frb de Melo, Patrícia Bgp Leal, Pedro C. Diniz, Rafael B. Moraes, Daniela Fs Pontes, Joselio Ea Queiroz, Glauco A. Westphal, Caroline C. Robinson, Adriane I. Rohden, Bruna P. Gimenes, Cátia M. Guterres, Itiana C. Madalena, Luiza V. Andrighetto, Natalia E. Giordani, Sabrina S. da Silva, Daiana B. da Silva, Daniel Sganzerla, Maicon Falavigna, Regis G. Rosa, Alexandre B. Cavalcanti, Cassiano Teixeira, Cristiano A. Franke, Flávia R. Machado, Joel de Andrade, Luciano Cp de Azevedo, Luciano S. Hammes, Maureen O Meade.
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