Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo assessments related to their non-cardiac procedures while having congenital heart disease.
1 visit (in-person)
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
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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