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

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04787705

Enrollment

547

Registered

2021-03-09

Start date

2020-03-10

Completion date

2025-12-31

Last updated

2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Congenital Heart Disease, Cardiac Surgery

Keywords

Prediction model

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
One-year mortality	365 days from the day of surgery.	One-year is defined as 365 days from the day of surgery.

Countries

Canada

Outcome results