An observational study in Congenital Heart Disease in Children, sponsored by Boston Children's Hospital. Recruiting at 10 sites in 2 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Boston Children's Hospital · Observational
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.
Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study.
All patients will be included.
Exclusion Criteria:
No intervention. It is observational
Mortality
Death
Time frame: during the procedure and up to 30-days following the procedure
Intensive Care Unit admission
The postoperative location of the patient is in the intensive care unit unexpectedly
Time frame: following the procedure and up to 72 hours
Postoperative mechanical support
Patient required a ventilator or noninvasive positive pressure ventilation
Time frame: following the procedure and up to 72 hours
Intraoperative cardiac event
Time frame: During the perioperative period
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
Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission
Time frame: following the procedure and up to 72 hours
Cardiac arrest
Patient required cardiopulmonary ressuscitation
Time frame: during the procedure and up to 72 hours
Neurologic injury
Defined as stroke or seizure by the provider
Time frame: Following the procedure and up to 72 hours
Renal Injury
Defined based on creatinine and glomerular filtration
Time frame: Following the procedure and up to 72 hours
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