Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors
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 , Grion Cintia Magalhães Carvalho , Bezerra Fernando Albuerne , Roman Fernando Roberto , Leite Francisco Olon , Ferraz Siqueira Íris Lima , Oliveira João Fernando Piccolo , de Oliveira 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 ,   DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network), de Stefano Laercio M , Cleto Marina CA , Zambrini Aline R , Banin Cintia , Douglas Maria OG , Borba Renato L , Boni Daniela , Monteiro Eliza MP , Manoel Airton LO , Parioto Neto Ciro , Lovato Wilson J , Cerantola Rodrigo B , Palma Leonardo C , Rojas Salomon O , Veiga Viviane C , Freitas Luciana S , Marco Roberto , Hirata Fabiano , Vieira Cinthia C , Jackiu Miriam , Santiago Alessandra D , Bertin Márcia R , Otsubo Luiz , Marques Ana L P , de Almeida Josileide F , Torres Martha P , dos Santos Gileade G , Gomes Márcia C , Nunes Caio L S , Moreira Felipe A , Simões Daniele S M V , Reis Leonardo d S , de Souza Mariane S L , de Castro Rismaria M R , Gameiro Valeska M N , Ferrari Regiane C , Ramos Daniela B , Passos Leny N M , Sodré América C B M , Pedrosa Rita C M P , de Almeida Eliana R B , Hirata Camila , Matiello Raquel DC , Machado Maria S , Castro Fernando , Gonçalves Gustavo P , de Oliveira Maria I G , Cançado Omar L , Miozzo Claire C , Montenegro Gyanna L M M , Gomes Noemy A C , Badoch Arlene T C G , Sarlo Rodrigo A , Pereira Gabriel T M , Marques Raissa M , Toledo Suely L A , Ruhling Ricardo K , Fernandez Benito O , Spalini Agenor , Monteiro Francisco A S , Medeiros Marizete P , de Oliveira Caroline L , Rech Gabriela S , Benck Patrícia S , Tomé Silvana R , de Mendonça Silvia EM , Wecki Vitor A , Machado Miriam MV , Segovia Carmen , Ghellere Aline , da Silva Charlene V , da Rocha Dagoberto F , Berbigier Eduardo , Leal Edvaldo , Pfuetzenreifer Felipe , Bourscheit Fernando , Toribio José L , Tannous Luana , Heberle Luana , Knihs Neide , Cardoso Paulo RC , Grando Marcelo , Veras Ludmylla BV , Albuquerque Gigliane MA , Hashimoto Régis A , Teles Mateus RT , Cruz Rosely B , Pinheiro Nelson AC , de Moraes Janapina MMF , Balzan Claudete M , Leite Lúcia RA , Oliveira Lis DP , Pereira Thattyane B , Novillo Edwin F , Batista Maxwendell G , de Campos Silvecler C , Ferreira Marcelo S , Bezerra Helen CA , Matos Paulo HL , Feijó Janaína , Ferreira Dernivania A , Machado Ana PRB , Santos Poliana N , de Souza Felipe FR , de Oliveira Daniela C , Dias Reis Graças M , Rolim Ana V , Magalhães Samira R , Reis Cleiriane , Costa Joel I , Carneiro Larissa SP , Passos Márcia MVS , dos Santos Gustavo M , de Souza José WB , Marinho Bruna BO , Salles Luiz DP , Gurgel José H , Fontenele Iranildo P , Bezerra Layanny TL , Costa Cristiano A , da Costa Israel F , Pinheiro Diego BS , de Moura Denise M , Cantidio Suzana , Moreira Jéssica PSL , Belém Telma A , Florentino Symoni BFQ , Carvalho Bruna S , Mendes Ciro L , do Nascimento Igor M , Araújo Paloma E , Araújo Maryjane AO , Alves Alexandre AG , Lima Heloisa RFO , Carvalho Silvia HCA , Aragão   Clayton , Santos Marko AF , Moraes Luiza MN , Sobrinho Henrique LCN , Siqueira Sylvia HAL , Silva Janaína R , Moraes Samyra P , Carvalho Janaína CW , Silva Luiz H , Silva Viviane M , Fornaciari Jander P , Curty Ana PN , Soares Ivens G , Pimentel Caroline S , Castilho Marco AM , Veiga Tânia LAA , Carvalho Frederico B , Ferreira Natasha P , Freitas Sylmara JZ , Sousa Fernanda CP , Laura Chen , Nobre Vandack A , Pereira Christiane FMHM , Gomes Amélia C , Oliveira Jeová F , Nasser Paula G , Ferreira Alexandre S , Moura Mara R , Oliveira Claudio D , Moreira Andressa S , Santiago Raquel B , Oliveira Marina F , Neves Ana OS , Silva Rodrigo CG , Almeida Roberto , Zili Karin A , Fernandes Alexsandro JS , Mezzaroba Ana L , Festti Josiane , Larangeira Alexandre S , Dhaese Thomas M , Hanke Simone Macedo , Arcaro Guilherme , Duarte Pericles AD , Padilha Elaine F , Tchaicka Cleber , Ayres Lizandra O , Tanita Marcos T , Oliveira Carlos A , Germano Almir , Dell´Agnolo Catia M , Freitas Rosane A , Barbosa Ellen S , Mezzavila Vanessa M , Santos Renata , Rigon Pedro , Weiwanko Itamar , Mroginski Cristiano , Pasa Waldir A , Ramthun Maikel , Pereira Jullye C , Flores César AB , Cwiertnia Patrícia B , Risson Ricardo GZ , Taborda Joseane A , Vieira Mayara F , Cassolli Tatiana E  , Singer Mariana P , Pereira Rosiane O , Oliveira Jaciara R , Lemos Melina AS , Toniol Vivianne CB , Souza Mariza A , Hayashi Ângelo Y , Paula Priscila LL , Bezerra Elza de Lara , Borges Fernanda GZ , Ramos Elaine S , Marochi Cibele A , Braga Jessyca , Sodré Alexander O , Entrago Letícia AP , Barcelos Thiago M , de Jesus Roberta C , Vianna Vitor M , de Melo Mônica SFS , Vaz Tais CB , Santos Flávio E , Begni Vladimir S , Cardoso Fábio F , Mallmann Lucas , Calvi Adriana , Franco Nelson B , Oliveira Angélica , Alves Flávio AC , Silveira Manoel NO , da Fonseca Deisi LO , Santini Susana , Rodrigues Filho Edison M , Bonow Fernanda P , Susin Ruth , Machado Kellen PM , de Aguiar Danielle M , Scheneider Caroline S , Braz Lidiane C , do Bem Carlos FP , Rech Tatiana H , de Aquino Vivian W , Teixeira Luciano O , Mendonça Viviane A , Bizarro Silvia Z , Calvete José O , Maito Lina , Henrich Sabrina F , PeLlizzaro Larissa A , Mecatti Giovana C , Filiponi Thiago C , Barbosa Felipe FP , Gozzoli Flávia , Ribeiro André S , Rosateli Paulo HP , Waked Zeher M , Quintal Ana P , Lobo Suzana MA , Sampaio Regiane , Morais Marcos , Rol James L , Orlando Bianca R , Grion Cintia MC , Bezerra Fernando A , Roman Fernando R , Leite Francisco O , Siqueira Íris LF , Oliveira João FP , de Oliveira LucioC , de Melo Maria FRB , Leal Patrícia BGP , Diniz Pedro C , Moraes Rafael B , Pontes Daniela FS , Queiroz Joselio EA , Westphal Glauco A , Robinson Caroline C , Rohden Adriane I , Gimenes Bruna P , Guterres Cátia M , Madalena Itiana C , Andrighetto Luiza V , Giordani Natalia E , da Silva Sabrina S , da Silva Daiana B , Sganzerla Daniel , Falavigna Maicon , Rosa Regis G , Cavalcanti Alexandre B , Teixeira Cassiano , Franke Cristiano A , Machado Flávia R , de Andrade Joel , de Azevedo Luciano CP , Hammes Luciano S , Meade Maureen O 
Published: December 2023

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