Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit: an Observational, Prospective, Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 528
- Locations
- 2
- Primary Endpoint
- Mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge, whichever occurs first
Study Overview
Brief Summary
The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures. Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile. Thus, information was sought regarding the patient characteristics, surgeries performed, anesthesia administered, incidence of intraoperative and postoperative complications, and risk factors associated with complication and mortality in the ICU. The main questions it aims to answer are:
- Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU.
- Risk factors associated with severe complications in patients who undergo cardiac surgery.
- Characteristics of patients, anesthesia and surgical procedures performed
- Incidence of severe intraoperative complications and moderate postoperative complications
- Evaluate the influence of accumulated fluid balance on outcomes, mortality, and length of ICU stay.
- Evaluate mortality in the ICU.
- Describe the risk factors associated with mortality.
Detailed Description
BACKGROUND The results of procedures in patients undergoing cardiovascular surgery are significantly influenced by preoperative risk factors and adequate perioperative management. Therefore, it is essential to develop tools and strategies that provide improvements in care to minimize complications.
SAMPLE SIZE CALCULATION The aim is to consecutively include 500 patients who undergo cardiac surgery. The incidence of death or severe postoperative complications in cardiovascular surgery during the first 3 postoperative days or until discharge from the ICU is approximately 20%. Therefore, with the inclusion of 500 patients, it will be possible to create a robust regression model by adding 10 independent variables.
PRIMARY OBJECTIVE Outcome composed of mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge, whichever occurs first. Severe postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications.
Cardiovascular complications: acute myocardial infarction, unplanned use of circulatory assist device, cardiac arrest with return of spontaneous circulation, severe hemodynamic instability.
Hematologic complication: severe bleeding. Pulmonary complications: acute respiratory distress syndrome (ARDS) with partial pressure of oxygen (PaO2) / inspired oxygen fraction (FiO2) ratio ≤ 250 (refractory to rescue maneuvers and ventilatory adjustment that persists for more than 1 hour), re-intubation in an unplanned manner.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (age 18 years or older).
- •Cardiac surgeries requiring postoperative care in the ICU.
Exclusion Criteria
- •Exclusive palliative care or advance directive expressing desire for limitation of life support (cardiopulmonary resuscitation, invasive mechanical ventilation, renal replacement therapy).
- •Moribund patient.
- •Surgery for implant of cardiac implantable electronic device (implantable cardioverter defibrillator, cardiac pacemaker).
- •Patients previously included in this study.
Outcomes
Primary Outcomes
Mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge, whichever occurs first
Time Frame: Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days
Severe postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications
Secondary Outcomes
- Describe the surgeries performed(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Evaluate the characteristics of the patients(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Describe the anesthesia performed(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Evaluate the incidence of severe intraoperative complications(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Assess the incidence of other postoperative complications (not included in the primary endpoint)(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Evaluate the influence of fluid balance on ICU mortality(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Assess the length of stay in the ICU(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)
- Evaluate the risk factors associated with ICU mortality(Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days)