Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

Active, not recruiting

• Conditions: Adult Congenital Heart Disease; Cardiac Surgery

• Registration Number: NCT04787705
• Lead Sponsor: University Health Network, Toronto

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 Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 547

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite adverse events	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 Outcome Measures

Name	Time	Method
One-year mortality	365 days from the day of surgery.	One-year is defined as 365 days from the day of surgery.

Trial Locations

Locations (1)

Toronto General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada