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

Recruiting

• Conditions: Congenital Heart Disease in Children

• Registration Number: NCT04604418
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit admission	following the procedure and up to 72 hours	The postoperative location of the patient is in the intensive care unit unexpectedly
Postoperative mechanical support	following the procedure and up to 72 hours	Patient required a ventilator or noninvasive positive pressure ventilation
Intraoperative cardiac event	During the perioperative period
Mortality	during the procedure and up to 30-days following the procedure	Death

Secondary Outcome Measures

Name	Time	Method
Cardiac arrest	during the procedure and up to 72 hours	Patient required cardiopulmonary ressuscitation
Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours	following the procedure and up to 72 hours	Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission
Neurologic injury	Following the procedure and up to 72 hours	Defined as stroke or seizure by the provider
Renal Injury	Following the procedure and up to 72 hours	Defined based on creatinine and glomerular filtration

Trial Locations

Locations (10)

Children's Hospital of the King's Daughter; 🇺🇸 Norfolk, Virginia, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Healthcare of Atlanta - Egleston Hospita; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Hospital for Sick Kids; 🇨🇦 Toronto, Ontario, Canada