Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Recruiting now

Conditions studied: Congenital Heart Disease in Children

In brief

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.

Key facts

Study ID

NCT04604418

Run by

Boston Children's Hospital

People needed

10000

Starts

2020-10-01

Expected to finish

2026-12-31

Last updated by the study team

2026-04-07

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Hospital for Sick Kids — Toronto, Ontario, Canada (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Children's Healthcare of Atlanta - Egleston Hospita — Atlanta, Georgia, United States
• Children's Hospital of the King's Daughter — Norfolk, Virginia, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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