Trial Outcomes & Findings for Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit (NCT NCT06154473)
NCT ID: NCT06154473
Last Updated: 2026-06-11
Results Overview
Severe postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications
COMPLETED
528 participants
Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days
2026-06-11
Participant Flow
Participants were recruited consecutively at 11 tertiary hospitals in Brazil between September 2023 and March 2025. Enrollment was initiated at each site only after approval by the respective Institutional Review Board. Participants were identified through routine surgical scheduling and perioperative workflows to ensure consecutive inclusion and minimize selection bias. No participants were lost to follow-up during the prespecified observation period.
This was a prospective, multicenter observational cohort study. No randomization or intervention assignment occurred. All enrolled participants received standard-of-care management as determined by the treating clinical teams at each participating institution. Treatment decisions, including surgical approach, anesthetic technique, intraoperative management, and postoperative care, were not influenced by study participation. No participants were excluded after enrollment
Participant milestones
| Measure |
Open Heart Surgery
Cohort of patient undergoing an open heart surgery. Open heart surgery is defined as a surgical procedure that involves making an incision in the chest to opening the chest wall to access and operate on the heart. The study will include patients who undergo valve repair, valve replacement, or coronary artery bypass grafting. In addition, combined surgery, define as valve surgery in combination with coronary artery bypass grafting, will also be included. Heart transplant will not be included.
|
Percutaneous Cardiovascular Surgery
Cohort of patient undergoing a percutaneous cardiovascular surgery. Percutaneous cardiovascular surgery is defined as a surgical procedure that involves making an incision in the skin to use a catheter-based approach to access and operate on the heart. The study will include patients who undergo transcatheter aortic valve implantation, valve in valve transcatheter aortic valve implantation and transcatheter mitral-valve repair or replacement.
|
|---|---|---|
|
Overall Study
STARTED
|
479
|
49
|
|
Overall Study
COMPLETED
|
479
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Open Heart Surgery
n=479 Participants
Cohort of patient undergoing an open heart surgery. Open heart surgery is defined as a surgical procedure that involves making an incision in the chest to opening the chest wall to access and operate on the heart. The study will include patients who undergo valve repair, valve replacement, or coronary artery bypass grafting. In addition, combined surgery, define as valve surgery in combination with coronary artery bypass grafting, will also be included. Heart transplant will not be included.
Open heart surgery group.: Patients undergoing open heart surgery.
|
Percutaneous Cardiovascular Surgery
n=49 Participants
Cohort of patient undergoing a percutaneous cardiovascular surgery. Percutaneous cardiovascular surgery is defined as a surgical procedure that involves making an incision in the skin to use a catheter-based approach to access and operate on the heart. The study will include patients who undergo transcatheter aortic valve implantation, valve in valve transcatheter aortic valve implantation and transcatheter mitral-valve repair or replacement.
Percutaneous cardiovascular surgery group.: Patients undergoing percutaneous cardiovascular surgery.
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12 • n=20 Participants
|
79 years
STANDARD_DEVIATION 9 • n=20 Participants
|
64 years
STANDARD_DEVIATION 12 • n=40 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
151 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
352 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
377 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
353 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
386 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
48 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
51 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
73 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Region of Enrollment
Brazil
|
479 participants
n=20 Participants
|
49 participants
n=20 Participants
|
528 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysSevere postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications
Outcome measures
| Measure |
Open Heart Surgery
n=479 Participants
Cohort of patient undergoing an open heart surgery. Open heart surgery is defined as a surgical procedure that involves making an incision in the chest to opening the chest wall to access and operate on the heart. The study will include patients who undergo valve repair, valve replacement, or coronary artery bypass grafting. In addition, combined surgery, define as valve surgery in combination with coronary artery bypass grafting, will also be included. Heart transplant will not be included.
|
Percutaneous Cardiovascular Surgery
n=49 Participants
Cohort of patient undergoing a percutaneous cardiovascular surgery. Percutaneous cardiovascular surgery is defined as a surgical procedure that involves making an incision in the skin to use a catheter-based approach to access and operate on the heart. The study will include patients who undergo transcatheter aortic valve implantation, valve in valve transcatheter aortic valve implantation and transcatheter mitral-valve repair or replacement.
|
|---|---|---|
|
Mortality or Severe Postoperative Complications Within the First 3 Postoperative Days or Until ICU Discharge, Whichever Occurs First
|
163 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysDescribe demographic characteristics of the patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysDescribe the type of surgeries performed. Description of the surgery as: emergency, urgent and elective surgery; open heart surgery or percutaneous cardiovascular surgery; valve repair (or replacement) and/or coronary artery bypass grafting
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysThe following anesthesia modalities will be considered and collected: general anesthesia, combined general anesthesia (general anesthesia and neuroaxis block) and sedation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysThe following severe intraoperative complications will be considered and collected: bronchospasm or difficulty with respiratory support, failure to exit cardiopulmonary bypass (CPB), cardiac arrest with return of spontaneous circulation, and excessive blood transfusion (≥ 4 units of packed red blood cells)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysThe following postoperative complications will be considered and collect: cardiovascular; pulmonary; neurological, gastrointestinal and metabolic
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysEvaluate the influence of fluid balance on ICU mortality. Determine if the increase in fluid balance during the ICU stay is associated with the increase in ICU mortality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysCalculated from the date and time of admission and date and time of actual ICU discharge (discharge or death)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative daysTo construct a logistic regression model to identify risk factors associated with increased ICU mortality.
Outcome measures
Outcome data not reported
Adverse Events
Open Heart Surgery
Percutaneous Cardiovascular Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Renato Carneiro de Freitas Chaves
Hospital Israelita Albert Einstein. Department of critical care medicine and anesthesiology. Avenida Albert Einstein, 627/701, 5 floor Zip code: 05651-901 - São Paulo (SP), Brazil.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place