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. 2025 Mar 10:37:e20250222.
doi: 10.62675/2965-2774.20250222. eCollection 2025.

Multicenter observational study of patients who underwent cardiac surgery and were hospitalized in an intensive care unit (BraSIS 2): study protocol and statistical analysis plan

Nair Naiara Barros de Vasconcelos  1 , Renato Carneiro de Freitas Chaves  1 , Carolina de Moraes Pellegrino  1 , Guilherme Martins de Souza  1 , Veronica Neves Fialho Queiroz  1 , Carmen Silvia Valente Barbas  1 , Flávio Takaoka  1 , Ricardo Luiz Cordioli  1 , Sandrigo Mangini  1 , Fabio de Vasconcelos Papa  2 , Hélio Penna Guimarães  1 , Adriano José Pereira  1 , Ary Serpa Neto  1 , Andre Gulinelli  1 , Anna Clara Legal  1 , Caio Vinicius Gouvêa Jaoude  1 , Eduardo Paolinelli  1 , Eric Benedet Lineburger  3 , Erick César de Farias Albuquerque  4 , Evaldo Gomes Ferreira Filho  5 , Fabio Barlem Hohmann  1 , Felipe Galdino  1 , Felipe Souza Lima Vianna  1 , Frederico Toledo Campo Dall'Orto  6 , Lucas Tramujas  7 , Luciano Ribeiro Pereira Silva  1 , Maxim Goncharov  7 , Paulo César Gottardo  8 , Roberto Rabello Filho  1 , Thais Dias Midega  1 , Vinicius Barbosa Galindo  1 , Vinícius Caldeira Quintão  9 , Viviane Cordeiro Veiga  10 , Thiago Domingos Corrêa  1 , João Manoel Silva Júnior  1
Affiliations

Multicenter observational study of patients who underwent cardiac surgery and were hospitalized in an intensive care unit (BraSIS 2): study protocol and statistical analysis plan

Nair Naiara Barros de Vasconcelos et al. Crit Care Sci. .

Abstract

Background: The perioperative management of patients undergoing cardiac surgery is highly complex and involves numerous factors. There is a strong association between cardiac surgery and perioperative complications. The Brazilian Surgical Identification Study (BraSIS 2) aims to assess the incidence of death and early postoperative complications, identify potential risk factors, and examine both the demographic characteristics of patients and the epidemiology of cardiovascular procedures.

Methods and analysis: BraSIS 2 is a multicenter observational study of patients who undergo cardiac surgery and who are admitted to the intensive care unit. The primary objective is to describe the risk factors and incidence of mortality or severe postoperative complications occurring within the first 3 postoperative days of cardiac surgery or until intensive care unit discharge (whichever event occurs first). Severe postoperative complications include acute myocardial infarction, acute respiratory distress syndrome, cardiorespiratory arrest with return of spontaneous circulation, Kidney Disease Improving Global Outcomes stage ≥ 2, a new surgical approach being conducted in an unscheduled event of urgency or emergency, renal replacement therapy, septic shock, severe bleeding, severe hemodynamic instability, stroke, unplanned reintubation, and unplanned use of a circulatory assistance device. The secondary outcomes include the evaluation of patient characteristics and descriptions of the performed surgeries and administered anesthesia. This study will also assess intraoperative and postoperative complications, as well as risk factors associated with postoperative complications and mortality. We expect to recruit 500 patients from at least 10 Brazilian intensive care units. Trial registration: NCT06154473; partial results.

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Conflict of interest statement

Conflicts of interest: None.

Figures

Figure 1
Figure 1. Study flowchart.
CABG - coronary artery bypass grafting; ICU - intensive care unit.
See this image and copyright information in PMC

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