Actively Recruiting

Age: 0 - 21Years
All Genders
ID04604418

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

Led by Boston Children's Hospital · Updated on 2026-04-07

10000

Participants Needed

10

Research Sites

8 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the outcomes and healthcare resource use in children with congenital heart disease (CHD) who undergo non-cardiac procedures. This study addresses a gap in understanding the risks and care needs for these patients by collecting detailed data from multiple hospitals. The goal is to improve risk prediction and guide quality improvement efforts nationally for pediatric CHD patients who require non-cardiac surgeries or procedures. This is an observational study without any experimental treatments. It gathers information from children and young adults up to 21 years old diagnosed with CHD who are having non-cardiac surgeries or procedures. The study excludes patients undergoing cardiac surgeries or cardiac catheterizations. The data collected spans patient characteristics, hospital settings, and provider details to better understand outcomes and resource use. Participants will be monitored for key outcomes including death during or up to 30 days after the procedure, admission to intensive care within 72 hours post-procedure, use of postoperative mechanical support, and occurrence of cardiac events during surgery. Additional outcomes tracked include cardiac arrest, neurologic injury, and kidney injury within 72 hours after the procedure. The information collected aims to inform healthcare providers about risks and resource needs for this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females ages birth to 21 years
  • Diagnosed with congenital heart disease
  • Undergoing a non-cardiac procedure, either surgical or nonsurgical
Not Eligible

You will not qualify if you...

  • Undergoing cardiac surgery, including pacemaker placement
  • Undergoing cardiac catheterization or electrophysiology study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of procedure

Participants undergo assessments related to their non-cardiac procedures while having congenital heart disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 days post-procedure

Participants are observed for health outcomes and resource use following their non-cardiac procedures.

Follow-up assessments up to 30 days

Trial Site Locations

Total: 10 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Active, Not Recruiting

2

Children's National Medical Center

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

Actively Recruiting

3

Children's Healthcare of Atlanta - Egleston Hospita

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

4

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

5

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Active, Not Recruiting

6

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

7

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

8

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

9

Children's Hospital of the King's Daughter

Norfolk, Virginia, United States, 23507

Terminated

10

Hospital for Sick Kids

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

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Research Team

V

Viviane Nasr, MD

R

Rachel Bernier

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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