Cardiac Surgery Clinical Trial
Official title:
Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation
Verified date | February 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 547 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital - University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Auckland City Hospital, Melbourne Health, Montreal Heart Institute, Providence Healthcare |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite adverse events | The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis. | 30 days from the day of surgery. | |
Secondary | One-year mortality | One-year is defined as 365 days from the day of surgery. | 365 days from the day of surgery. |
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