Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 547
- Locations
- 1
- Primary Endpoint
- Composite adverse events
Study Overview
Brief Summary
This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.
Detailed Description
The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, >3 chest incisions, anatomy diagnosis, and Body Mass Index <20 and >28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury.
This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all ACHD patients >16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019.
Exclusion Criteria
- •CHD patients <16 years of age
- •ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding
- •Non-cardiac surgery procedures and cardiology laboratory interventions
Outcomes
Primary Outcomes
Composite adverse events
Time Frame: 30 days from the day of surgery.
The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis.
Secondary Outcomes
- One-year mortality(365 days from the day of surgery.)