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Recruiting NCT04604418

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

— Observational Congenital Heart Disease in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention. It is observational.
Who it may be relevant to
Registry conditions: Congenital Heart Disease in Children. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other No intervention. It is observational
    No intervention. It is observational

Primary outcome measures

  • Mortality [Time frame: during the procedure and up to 30-days following the procedure]
  • Intensive Care Unit admission [Time frame: following the procedure and up to 72 hours]
  • Postoperative mechanical support [Time frame: following the procedure and up to 72 hours]
  • Intraoperative cardiac event [Time frame: During the perioperative period]
Secondary outcome measures (4)
  • 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]
  • Cardiac arrest [Time frame: during the procedure and up to 72 hours]
  • Neurologic injury [Time frame: Following the procedure and up to 72 hours]
  • Renal Injury [Time frame: Following the procedure and up to 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 9 centers
  • University of California, Los Angeles — Los Angeles
  • Children's National Medical Center — Washington D.C.
  • Children's Healthcare of Atlanta - Egleston Hospita — Atlanta
  • Boston Children's Hospital — Boston
  • University of Minnesota Medical Center — Minneapolis
  • Children's Hospital of Philadelphia — Philadelphia
  • Vanderbilt University Medical Center — Nashville
  • Texas Children's Hospital — Houston
  • … and 1 more center
Canada · 1 center
  • Hospital for Sick Kids — Toronto

Identifiers

NCT: NCT04604418 · IRB-P00035008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗