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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boston Children's Hospital
Study ID
NCT04604418
Status
Recruiting
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Conditions

  • Congenital Heart Disease in Children

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention. It is observational — OTHER
    No intervention. It is observational

Study Details

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 Dates

Start date
Oct 1, 2020
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10,000 participants (estimated)

Primary Outcome Measure

Mortality [ Time Frame: during the procedure and up to 30-days following the procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
Children's National Medical CenterWashington D.C.District of Columbia20310
Nina Deutsch, MD
Children's Healthcare of Atlanta - Egleston HospitaAtlantaGeorgia30322-
Boston Children's HospitalBostonMassachusetts02115
Viviane Nasr, MD
University of Minnesota Medical CenterMinneapolisMinnesota55455-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Susan Nicolson
Vanderbilt University Medical CenterNashvilleTennessee37232
Michael Kuntz, MD
[email protected]
615-322-5000
Texas Children's HospitalHoustonTexas77030
Wanda Miller Hance
Children's Hospital of the King's DaughterNorfolkVirginia23507-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAChildren's National Medical Center· Washington D.C., DCChildren's Healthcare of Atlanta - Egleston Hospita· Atlanta, GABoston Children's Hospital· Boston, MAUniversity of Minnesota Medical Center· Minneapolis, MNChildren's Hospital of Philadelphia· Philadelphia, PA

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