NCT04787705

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

Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 547 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Congenital Heart Disease
• Cardiac Surgery

Timeline

• Start date: 2020-03-10
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-03-09
• Last updated: 2024-03-07

Locations

1 site across 1 country: Canada