Clinical trial NCT04604418: Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Official title: Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease in Children
Keywords: Perioperative risk prediction
Adverse Postoperative Outcomes
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Vanderbilt University Medical Center
name: University of Minnesota
name: Children's Hospital of Philadelphia
name: Children's Healthcare of Atlanta
name: Baylor College of Medicine
name: Children's National Med Center
name: Children's Hospital of The King's Daughters
name: University of California, Los Angeles
First posted: 2020-10-27
Enrollment: 10000
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: during the procedure and up to 30-days following the procedure
measure: Intensive Care Unit admission
timeFrame: following the procedure and up to 72 hours
measure: Postoperative mechanical support
timeFrame: following the procedure and up to 72 hours
measure: Intraoperative cardiac event
timeFrame: During the perioperative period
Secondary outcomes:
measure: 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
timeFrame: following the procedure and up to 72 hours
measure: Cardiac arrest
timeFrame: during the procedure and up to 72 hours
measure: Neurologic injury
timeFrame: Following the procedure and up to 72 hours
measure: Renal Injury
timeFrame: Following the procedure and up to 72 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Egleston Hospita
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughter
state: Virginia
city: Toronto
country: Canada
facility: Hospital for Sick Kids
state: Ontario
Study officials:
affiliation: Boston Children's Hospital
name: Viviane Nasr, MD
role: PRINCIPAL_INVESTIGATOR
References: