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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:

• Males or females ages birth to 21 years.

• Patients diagnosed with congenital heart disease

• Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Locations
United States
California
University of California, Los Angeles
ACTIVE_NOT_RECRUITING
Los Angeles
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Georgia
Children's Healthcare of Atlanta - Egleston Hospita
ACTIVE_NOT_RECRUITING
Atlanta
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota Medical Center
ACTIVE_NOT_RECRUITING
Minneapolis
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
Virginia
Children's Hospital of the King's Daughter
TERMINATED
Norfolk
Other Locations
Canada
Hospital for Sick Kids
RECRUITING
Toronto
Contact Information
Primary
Viviane Nasr, MD
viviane.nasr@childrens.harvard.edu
617-355-6225
Backup
Rachel Bernier
Rachel.Bernier@childrens.harvard.edu
857-218-5348
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10000
Related Therapeutic Areas
Sponsors
Collaborators: Children's National Research Institute, Vanderbilt University Medical Center, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, Children's Hospital of The King's Daughters, Baylor College of Medicine, University of California, Los Angeles, University of Minnesota, The Hospital for Sick Children
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov