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

Congenital Heart Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604418
• Other study ID #: IRB-P00035008
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Boston Children's Hospital
• Contact: Viviane Nasr, MD
• Phone: 617-355-6225
• Email: viviane.nasr[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• No intervention. It is observational
No intervention. It is observational

Locations

Country	Name	City	State
Canada	Hospital for Sick Kids	Toronto	Ontario
United States	Children's Healthcare of Atlanta - Egleston Hospita	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Texas Children's Hospital	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (9)

Lead Sponsor	Collaborator
Boston Children's Hospital	Baylor College of Medicine, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, Children's National Research Institute, The Hospital for Sick Children, University of California, Los Angeles, University of Minnesota, Vanderbilt University Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death	during the procedure and up to 30-days following the procedure
Primary	Intensive Care Unit admission	The postoperative location of the patient is in the intensive care unit unexpectedly	following the procedure and up to 72 hours
Primary	Postoperative mechanical support	Patient required a ventilator or noninvasive positive pressure ventilation	following the procedure and up to 72 hours
Secondary	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	following the procedure and up to 72 hours
Secondary	Cardiac arrest	Patient required cardiopulmonary ressuscitation	during the procedure and up to 72 hours
Secondary	Neurologic injury	Defined as stroke or seizure by the provider	Following the procedure and up to 72 hours
Secondary	Renal Injury	Defined based on creatinine and glomerular filtration	Following the procedure and up to 72 hours