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

NCT04604418 | Recruiting

• 1 other identifier: IRB-P00035008
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 10

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.

Conditions

Congenital Heart Disease in Children

Keywords

Perioperative risk prediction; Adverse Postoperative Outcomes

Outcome Measures

Primary Outcomes (4)

• Mortality

  Death

  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

  following the procedure and up to 72 hours

• Postoperative mechanical support

  Patient required a ventilator or noninvasive positive pressure ventilation

  following the procedure and up to 72 hours

• Intraoperative cardiac event

  During the perioperative period

Secondary Outcomes (4)

• 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

• Cardiac arrest

  during the procedure and up to 72 hours

• Neurologic injury

  Following the procedure and up to 72 hours

• Renal Injury

  Following the procedure and up to 72 hours

Interventions

No intervention. It is observational OTHER

No intervention. It is observational

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Males or females ages birth to 21 years.
• Patients diagnosed with congenital heart disease
• Patients undergoing a noncardiac procedure (surgical or nonsurgical)

You may not qualify if:

• Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
• Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Sponsors & Collaborators

• Boston Children's Hospital: lead
• The Hospital for Sick Children: collaborator
• Vanderbilt University Medical Center: collaborator
• University of Minnesota: collaborator
• Children's Hospital of Philadelphia: collaborator
• Children's Healthcare of Atlanta: collaborator
• Baylor College of Medicine: collaborator
• Children's National Research Institute: collaborator
• Children's Hospital of The King's Daughters: collaborator
• University of California, Los Angeles: collaborator

Study Sites (10)

University of California, Los Angeles

Los Angeles, California, 90095, United States

ACTIVE NOT RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20310, United States

RECRUITING

Children's Healthcare of Atlanta - Egleston Hospita

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

ACTIVE NOT RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Children's Hospital of the King's Daughter

Norfolk, Virginia, 23507, United States

TERMINATED

Hospital for Sick Kids

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Study Officials

• Viviane Nasr, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Nasr, MD

CONTACT

617-355-6225; viviane.nasr@childrens.harvard.edu

Rachel Bernier

CONTACT

857-218-5348; Rachel.Bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 27, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (9); CA (1)