Characteristics and outcomes of patients with COVID-19 admitted to the ICU in a university hospital in São Paulo, Brazil - study protocol

Juliana C Ferreira, Yeh-Li Ho, Bruno A M P Besen, Luiz M S Malbuisson, Leandro U Taniguchi, Pedro V Mendes, Eduardo L V Costa, Marcelo Park, Renato Daltro-Oliveira, Roberta M L Roepke, João M Silva Jr, Maria José C Carmona, Carlos Roberto Ribeiro Carvalho, EPICCoV Study Group, Adriana Hirota, Alberto Kendy Kanasiro, Alessandra Crescenzi, Amanda Coelho Fernandes, Anna Miethke-Morais, Arthur Petrillo Bellintani, Artur Ribeiro Canasiro, Bárbara Vieira Carneiro, Beatriz Keiko Zanbon, Bernardo Pinheiro De Senna Nogueira Batista, Bianca Ruiz Nicolao, Bruno Adler Maccagnan Pinheiro Besen, Bruno Biselli, Bruno Rocha De Macedo, Caio Machado Gomes De Toledo, Carlos Eduardo Pompilio, Carlos Roberto Ribeiro De Carvalho, Caroline Gomes Mol, Cassio Stipanich, Caue Gasparotto Bueno, Cibele Garzillo, Clarice Tanaka, Daniel Neves Forte, Daniel Joelsons, Daniele Robira, Eduardo Leite Vieira Costa, Elson Mendes Da Silva Júnior, Fabiane Aliotti Regalio, Gabriela Cardoso Segura, Gustavo Brasil Marcelino, Giulia Sefrin Louro, Yeh-Li Ho, Isabela Argollo Ferreira, Jeison de Oliveira Gois, Joao Manoel Da Silva Junior, Jose Otto Reusing Junior, Julia Fray Ribeiro, Juliana Carvalho Ferreira, Karine Vusberg Galleti, Katia Regina Silva, Larissa Padrao Isensee, Larissa dos Santos Oliveira, Leandro Utino Taniguchi, Leila Suemi Letaif, Lígia Trombetta Lima, Lucas Yongsoo Park, Lucas Chaves Netto, Luciana Cassimiro Nobrega, Luciana Haddad, Ludhmila Hajjar, Luiz Marcelo Malbouisson, Manuela Cristina Adsuara Pandolfi, Marcelo Park, Maria José Carvalho Carmona, Maria Castilho Prandini H De Andrade, Mariana Moreira Santos, Matheus Pereira Bateloche, Mayra Akimi Suiama, Mayron Faria de Oliveira, Mayson Laercio Sousa, Michelle Louvaes, Natassja Huemer, Pedro Mendes, Paulo Ricardo Gessolo Lins, Pedro Gaspar Dos Santos, Pedro Ferreira Paiva Moreira, Renata Mello Guazzelli, Renato Batista Dos Reis, Renato Daltro De Oliveira, Roberta Muriel Longo Roepke, Rodolpho Augusto De Moura Pedro, Rodrigo Kondo, Samia Zahi Rached, Sergio Roberto Silveira Da Fonseca, Thais Sousa Borges, Thalissa Ferreira, Vilson Cobello Junior, Vivian Vieira Tenório Sales, Willaby Serafim Cassa Ferreira, Juliana C Ferreira, Yeh-Li Ho, Bruno A M P Besen, Luiz M S Malbuisson, Leandro U Taniguchi, Pedro V Mendes, Eduardo L V Costa, Marcelo Park, Renato Daltro-Oliveira, Roberta M L Roepke, João M Silva Jr, Maria José C Carmona, Carlos Roberto Ribeiro Carvalho, EPICCoV Study Group, Adriana Hirota, Alberto Kendy Kanasiro, Alessandra Crescenzi, Amanda Coelho Fernandes, Anna Miethke-Morais, Arthur Petrillo Bellintani, Artur Ribeiro Canasiro, Bárbara Vieira Carneiro, Beatriz Keiko Zanbon, Bernardo Pinheiro De Senna Nogueira Batista, Bianca Ruiz Nicolao, Bruno Adler Maccagnan Pinheiro Besen, Bruno Biselli, Bruno Rocha De Macedo, Caio Machado Gomes De Toledo, Carlos Eduardo Pompilio, Carlos Roberto Ribeiro De Carvalho, Caroline Gomes Mol, Cassio Stipanich, Caue Gasparotto Bueno, Cibele Garzillo, Clarice Tanaka, Daniel Neves Forte, Daniel Joelsons, Daniele Robira, Eduardo Leite Vieira Costa, Elson Mendes Da Silva Júnior, Fabiane Aliotti Regalio, Gabriela Cardoso Segura, Gustavo Brasil Marcelino, Giulia Sefrin Louro, Yeh-Li Ho, Isabela Argollo Ferreira, Jeison de Oliveira Gois, Joao Manoel Da Silva Junior, Jose Otto Reusing Junior, Julia Fray Ribeiro, Juliana Carvalho Ferreira, Karine Vusberg Galleti, Katia Regina Silva, Larissa Padrao Isensee, Larissa dos Santos Oliveira, Leandro Utino Taniguchi, Leila Suemi Letaif, Lígia Trombetta Lima, Lucas Yongsoo Park, Lucas Chaves Netto, Luciana Cassimiro Nobrega, Luciana Haddad, Ludhmila Hajjar, Luiz Marcelo Malbouisson, Manuela Cristina Adsuara Pandolfi, Marcelo Park, Maria José Carvalho Carmona, Maria Castilho Prandini H De Andrade, Mariana Moreira Santos, Matheus Pereira Bateloche, Mayra Akimi Suiama, Mayron Faria de Oliveira, Mayson Laercio Sousa, Michelle Louvaes, Natassja Huemer, Pedro Mendes, Paulo Ricardo Gessolo Lins, Pedro Gaspar Dos Santos, Pedro Ferreira Paiva Moreira, Renata Mello Guazzelli, Renato Batista Dos Reis, Renato Daltro De Oliveira, Roberta Muriel Longo Roepke, Rodolpho Augusto De Moura Pedro, Rodrigo Kondo, Samia Zahi Rached, Sergio Roberto Silveira Da Fonseca, Thais Sousa Borges, Thalissa Ferreira, Vilson Cobello Junior, Vivian Vieira Tenório Sales, Willaby Serafim Cassa Ferreira

Abstract

Objectives: We designed a cohort study to describe characteristics and outcomes of patients with coronavirus disease (COVID-19) admitted to the intensive care unit (ICU) in the largest public hospital in Sao Paulo, Brazil, as Latin America becomes the epicenter of the pandemic.

Methods: This is the protocol for a study being conducted at an academic hospital in Brazil with 300 adult ICU beds dedicated to COVID-19 patients. We will include adult patients admitted to the ICU with suspected or confirmed COVID-19 during the study period. The main outcome is ICU survival at 28 days. Data will be collected prospectively and retrospectively by trained investigators from the hospital's electronic medical records, using an electronic data capture tool. We will collect data on demographics, comorbidities, severity of disease, and laboratorial test results at admission. Information on the need for advanced life support and ventilator parameters will be collected during ICU stay. Patients will be followed up for 28 days in the ICU and 60 days in the hospital. We will plot Kaplan-Meier curves to estimate ICU and hospital survival and perform survival analysis using the Cox proportional hazards model to identify the main risk factors for mortality. ClinicalTrials.gov: NCT04378582.

Results: We expect to include a large sample of patients with COVID-19 admitted to the ICU and to be able to provide data on admission characteristics, use of advanced life support, ICU survival at 28 days, and hospital survival at 60 days.

Conclusions: This study will provide epidemiological data about critically ill patients with COVID-19 in Brazil, which could inform health policy and resource allocation in low- and middle-income countries.

Conflict of interest statement

No potential conflict of interest was reported.

Figures

Figure 1. Expected flow of potentially eligible…
Figure 1. Expected flow of potentially eligible participants in the study.
Figure 2. Overview of data collection and…
Figure 2. Overview of data collection and follow up in the study.

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Source: PubMed

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