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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04787705
Other study ID # 18-5588
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 10, 2020
Est. completion date December 2025

Study information

Verified date February 2024
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Canada Toronto General Hospital - University Health Network Toronto Ontario

Sponsors (5)

Lead Sponsor Collaborator
University Health Network, Toronto Auckland City Hospital, Melbourne Health, Montreal Heart Institute, Providence Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

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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