1. DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial
- Author
-
Luciano Serpa Hammes, Fernando A. Bozza, Itiana Cardoso Madalena, Pedro Carvalho Diniz, Sabrina Souza da Silva, Rafael Barberena Moraes, Cassiano Teixeira, Rosana Reis Nothen, Fernando Roberto Roman, Flávia Ribeiro Machado, Natalia Elis Giordani, Alexandre Biasi, Luciano Cesar Pontes Azevedo, Daniel Sganzerla, João Fernando Picollo Oliveira, Cátia Moreira Guterres, Patrícia Spessatto Benck, Joel de Andrade, Adriane Isabel Rohden, Maria de Fátima Rodrigues Buarque de Melo, Cintia Magalhães Carvalho Grion, Caroline Cabral Robinson, Flávio André Cardona Alves, Luiza Vitelo Andrighetto, Thattyane Borba Pereira, Giovana Colozza Mecatti, Glauco Adrieno Westphal, Vandack Nobre, Daiana Barbosa da Silva, Regis Goulart Rosa, Cristiano Augusto Franke, Maicon Falavigna, Maureen O. Meade, and Débora Zechmeister do Prado
- Subjects
medicine.medical_specialty ,Brain Death ,Tissue and Organ Procurement ,cardiac arrest ,Organ transplantation ,quality improvement ,03 medical and health sciences ,0302 clinical medicine ,Informed consent ,organ donation ,Intensive care ,Outcome Assessment, Health Care ,medicine ,Protocol ,Humans ,030212 general & internal medicine ,Organ donation ,Cluster randomised controlled trial ,Evidence-Based Medicine ,business.industry ,Intensive Care ,030208 emergency & critical care medicine ,General Medicine ,medicine.disease ,Institutional review board ,Checklist ,Intensive Care Units ,Donation ,Medical emergency ,business ,Brazil - Abstract
IntroductionThere is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest.Methods and analysisThe study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor.Ethics and disseminationThe institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals.Trial registration numberNCT03179020; Pre-results.
- Published
- 2019