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

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04604418
• Collaborator: Children's National Research Institute (Other), The Hospital for Sick Children (Other), Children's Healthcare of Atlanta (Other), Baylor College of Medicine (Other), Vanderbilt University Medical Center (Other), University of Minnesota (Other), Children's Hospital of Philadelphia (Other), University of California, Los Angeles (Other)
• Enrollment: 10,000
• Locations: 9
• Anticipated Duration (Months): 39
• Patients Per Site: 1111.1
• Patients Per Site Per Month: 28.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children	Other: No intervention. It is observational

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Mortality [during the procedure and up to 30-days following the procedure]

   Death

2. Intensive Care Unit admission [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 [following the procedure and up to 72 hours]

   Patient required a ventilator or noninvasive positive pressure ventilation

Secondary Outcome Measures

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 [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 [during the procedure and up to 72 hours]

   Patient required cardiopulmonary ressuscitation

3. Neurologic injury [Following the procedure and up to 72 hours]

   Defined as stroke or seizure by the provider

4. Renal Injury [Following the procedure and up to 72 hours]

   Defined based on creatinine and glomerular filtration

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males or females ages birth to 21 years.

2. Patients diagnosed with congenital heart disease

3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Exclusion Criteria:

1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.

2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Children's National Medical Center	Washington	District of Columbia	United States	20310
3	Children's Healthcare of Atlanta - Egleston Hospita	Atlanta	Georgia	United States	30322
4	Boston Children's Hospital	Boston	Massachusetts	United States	02115
5	University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
7	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
8	Texas Children's Hospital	Houston	Texas	United States	77030
9	Hospital for Sick Kids	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viviane Nasr, Associate Professor, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT04604418
• Other Study ID Numbers: IRB-P00035008
• First Posted: Oct 27, 2020
• Last Update Posted: Nov 5, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Viviane Nasr, Associate Professor, Boston Children's Hospital: Perioperative risk prediction; Adverse Postoperative Outcomes
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Nov 5, 2021