Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Dec 1;6(12):e2346901.
doi: 10.1001/jamanetworkopen.2023.46901.

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

Glauco A Westphal  1   2   3 , Caroline Cabral Robinson  1 , Natalia Elis Giordani  1   4 , Cassiano Teixeira  5   6 , Adriane Isabel Rohden  1 , Bruna Dos Passos Gimenes  1 , Cátia Moreira Guterres  1 , Itiana Cardoso Madalena  1 , Luiza Vitelo Andrighetto  1 , Sabrina Souza da Silva  1 , Daiana Barbosa da Silva  1 , Daniel Sganzerla  1 , Alexandre Biasi Cavalcanti  7 , Cristiano Augusto Franke  5   8 , Fernando Augusto Bozza  9   10 , Flávia Ribeiro Machado  11 , Joel de Andrade  2 , Luciano Cesar Pontes Azevedo  12 , Silvana Schneider  13 , Bianca Rodrigues Orlando  14   15 , Cintia Magalhães Carvalho Grion  16   17 , Fernando Albuerne Bezerra  18 , Fernando Roberto Roman  19 , Francisco Olon Leite Jr  20 , Íris Lima Ferraz Siqueira  21 , João Fernando Piccolo Oliveira  22 , Lúcio Couto de Oliveira Jr  23 , Maria de Fátima Rodrigues Buarque de Melo  24 , Patrícia Berg Gonçalves Pereira Leal  25 , Pedro Carvalho Diniz  26 , Rafael Barbarena Moraes  27 , Daniela Ferreira Salomão Pontes  28 , Josélio Emar Araújo Queiroz  28 , Luciano Serpa Hammes  1 , Maureen O Meade  29 , Regis Goulart Rosa  1 , Maicon Falavigna  1   30   31 ; DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network)
Collaborators, Affiliations
Randomized Controlled Trial

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

Glauco A Westphal et al. JAMA Netw Open. .

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Ms Giordani reported receiving grants from Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS) of the Brazilian Ministry of Health during the conduct of the study. Mrs Rohden reported receiving personal fees from PROADI-SUS of the Brazilian Ministry of Health during the conduct of the study. Mrs Guterres reported receiving personal fees from PROADI-SUS of the Brazilian Ministry of Health during the conduct of the study. Prof Pontes Azevedo reported receiving personal fees from MSD, Nestle, and Baxter outside the submitted work. Dr Schneider reported receiving grants from PROADI-SUS of the Brazilian Ministry of Health during the conduct of the study. Dr Rosa reported receiving grants from Brazilian Ministry of Health during the conduct of the study as well as grants from Pfizer and MSD outside the submitted work. Dr Falavigna reported receiving grants from Brazilian Ministry of Health during the conduct of the study; personal fees from Pfizer, MSD, PTC, Merck, Amryt, Roche, JCR Pharma, United Medical, Sanofi, Novartis, and AstraZeneca outside the submitted work; and grants from Pfizer and MSD outside the submitted work as well as reported being a member of GRADE Working Group, managing director of HTAnalyze Consulting, and managing director of Inova Medical. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flowchart
ICU indicates intensive care unit; ITT, intention to treat.
Figure 2.
Figure 2.. Bedside Goal-Directed Checklist to Guide the Care of Brain-Dead Potential Donors
ΔPp indicates pulse pressure respiratory variation; ΔSV, stroke volume respiratory variation; CVP, central venous pressure; FiO2, fraction of inspired oxygen; H2O, water; Hb, hemoglobin; IV, intravenous; K+, potassium; MAP, mean arterial pressure; Mg++, magnesium; Na+, sodium; PEEP, positive end-expiratory pressure; SaO2, arterial oxygen saturation; and Vt, tidal volume.
Figure 3.
Figure 3.. Brain-Dead Potential Donors Lost Due to Cardiac Arrest in the Study Groups and by Adherence to the Intervention
RR indicates risk ratio.
See this image and copyright information in PMC

References

    1. The Madrid resolution on organ donation and transplantation: national responsibility in meeting the needs of patients, guided by the WHO principles. Transplantation. 2011;91(suppl 11):S29-S31. doi:10.1097/01.tp.0000399131.74618.a5 - DOI - PubMed
    1. Meyfroidt G, Gunst J, Martin-Loeches I, et al. . Management of the brain-dead donor in the ICU: general and specific therapy to improve transplantable organ quality. Intensive Care Med. 2019;45(3):343-353. doi:10.1007/s00134-019-05551-y - DOI - PMC - PubMed
    1. Tullius SG, Rabb H. Improving the supply and quality of deceased-donor organs for transplantation. N Engl J Med. 2018;378(20):1920-1929. doi:10.1056/NEJMra1507080 - DOI - PubMed
    1. Dictus C, Vienenkoetter B, Esmaeilzadeh M, Unterberg A, Ahmadi R. Critical care management of potential organ donors: our current standard. Clin Transplant. 2009;23(suppl 21):2-9. doi:10.1111/j.1399-0012.2009.01102.x - DOI - PubMed
    1. de la Rosa G, Domínguez-Gil B, Matesanz R, et al. . Continuously evaluating performance in deceased donation: the Spanish quality assurance program. Am J Transplant. 2012;12(9):2507-2513. doi:10.1111/j.1600-6143.2012.04138.x - DOI - PubMed

Publication types

Associated data