Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04604418

Conditions

Congenital Heart Disease in Children

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

No intervention. It is observational

Study Details

Brief summary:

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.

However, the information provided by national databases lack granularity and the information from single institutional data is limited.

This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.

Conditions

Congenital Heart Disease in Children

Study ID

NCT04604418

Start date

Oct 1, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males or females ages birth to 21 years.
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Exclusion Criteria:

1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention. It is observational

No intervention. It is observational

Primary outcome measure

  • Mortality [ Time Frame: during the procedure and up to 30-days following the procedure ]
  • Intensive Care Unit admission [ Time Frame: following the procedure and up to 72 hours ]
  • Postoperative mechanical support [ Time Frame: following the procedure and up to 72 hours ]
  • Intraoperative cardiac event [ Time Frame: During the perioperative period ]

Central Contacts and Locations

Locations

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20310

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Hospital for Sick Kids

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Perioperative risk prediction
  • Adverse Postoperative Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-07.