Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604418
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Viviane Nasr, Boston Children's Hospital

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
Congenital Heart Disease in Children Other: No intervention. It is observational

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention. It is observational
    No intervention. It is observational


Primary Outcome Measures :
  1. Mortality [ Time Frame: during the procedure and up to 30-days following the procedure ]
    Death

  2. Intensive Care Unit admission [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during the procedure and up to 72 hours ]
    Patient required cardiopulmonary ressuscitation

  3. Neurologic injury [ Time Frame: Following the procedure and up to 72 hours ]
    Defined as stroke or seizure by the provider

  4. Renal Injury [ Time Frame: Following the procedure and up to 72 hours ]
    Defined based on creatinine and glomerular filtration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604418


Contacts
Layout table for location contacts
Contact: Viviane Nasr, MD 617-355-6225 viviane.nasr@childrens.harvard.edu
Contact: Rachel Bernier 857-218-5348 Rachel.Bernier@childrens.harvard.edu

Locations
Layout table for location information
United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Tiffany Williams, MD, PhD         
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20310
Contact: Nina Deutsch, MD         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Hospita Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Scott Kolesky, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Viviane Nasr, MD         
United States, Minnesota
University of Minnesota Medical Center Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Benjamin Kloesel         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Susan Nicolson         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: John Dave Moore, MD         
United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Wanda Miller Hance         
Canada, Ontario
Hospital for Sick Kids Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: David Faraoni, MD, PhD         
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
Layout table for investigator information
Principal Investigator: Viviane Nasr, MD Boston Children's Hospital
Layout table for additonal information
Responsible Party: Viviane Nasr, Associate Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04604418    
Other Study ID Numbers: IRB-P00035008
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viviane Nasr, Boston Children's Hospital:
Perioperative risk prediction
Adverse Postoperative Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities