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NCT Number: NCT04604418

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

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.

Recruiting

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Kids, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

No intervention. It is observational

Other

No intervention. It is observational

Primary outcomes

  1. Mortality

    Time frame: during the procedure and up to 30-days following the procedure

    Death

  2. Intensive Care Unit admission

    Time frame: following the procedure and up to 72 hours

    The postoperative location of the patient is in the intensive care unit unexpectedly

  3. Postoperative mechanical support

    Time frame: following the procedure and up to 72 hours

    Patient required a ventilator or noninvasive positive pressure ventilation

  4. Intraoperative cardiac event

    Time frame: During the perioperative period

Secondary outcomes

  1. 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

    Time frame: 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

  2. Cardiac arrest

    Time frame: during the procedure and up to 72 hours

    Patient required cardiopulmonary ressuscitation

  3. Neurologic injury

    Time frame: Following the procedure and up to 72 hours

    Defined as stroke or seizure by the provider

  4. Renal Injury

    Time frame: Following the procedure and up to 72 hours

    Defined based on creatinine and glomerular filtration

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Bernier

CONTACT

[email protected]

857-218-5348

Viviane Nasr, MD

CONTACT

[email protected]

617-355-6225

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2020
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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