Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04604418
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'during the procedure and up to 30-days following the procedure', 'description': 'Death'}, {'measure': 'Intensive Care Unit admission', 'timeFrame': 'following the procedure and up to 72 hours', 'description': 'The postoperative location of the patient is in the intensive care unit unexpectedly'}, {'measure': 'Postoperative mechanical support', 'timeFrame': 'following the procedure and up to 72 hours', 'description': 'Patient required a ventilator or noninvasive positive pressure ventilation'}, {'measure': 'Intraoperative cardiac event', 'timeFrame': 'During the perioperative period'}], 'secondaryOutcomes': [{'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', 'description': 'Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission'}, {'measure': 'Cardiac arrest', 'timeFrame': 'during the procedure and up to 72 hours', 'description': 'Patient required cardiopulmonary ressuscitation'}, {'measure': 'Neurologic injury', 'timeFrame': 'Following the procedure and up to 72 hours', 'description': 'Defined as stroke or seizure by the provider'}, {'measure': 'Renal Injury', 'timeFrame': 'Following the procedure and up to 72 hours', 'description': 'Defined based on creatinine and glomerular filtration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perioperative risk prediction', 'Adverse Postoperative Outcomes'], 'conditions': ['Congenital Heart Disease in Children']}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, the information provided by national databases lack granularity and the information from single institutional data is limited.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study.\n\nAll patients will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females ages birth to 21 years.\n2. Patients diagnosed with congenital heart disease\n3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)\n\nExclusion Criteria:\n\n1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.\n2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study'}, 'identificationModule': {'nctId': 'NCT04604418', 'briefTitle': 'Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures', 'orgStudyIdInfo': {'id': 'IRB-P00035008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention. It is observational', 'type': 'OTHER', 'description': 'No intervention. It is observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20310', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nina Deutsch, MD', 'role': 'CONTACT'}], 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Egleston Hospita", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viviane Nasr, MD', 'role': 'CONTACT'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Nicolson', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Kuntz, MD', 'role': 'CONTACT', 'email': 'michael.kuntz@vumc.org', 'phone': '615-322-5000'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wanda Miller Hance', 'role': 'CONTACT'}], 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'TERMINATED', 'country': 'United States', 'facility': "Children's Hospital of the King's Daughter", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vannessa Chin, MD', 'role': 'CONTACT', 'email': 'vannessa.chin@sickkids.ca', 'phone': '416-813-7445'}], 'facility': 'Hospital for Sick Kids', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Viviane Nasr, MD', 'role': 'CONTACT', 'email': 'viviane.nasr@childrens.harvard.edu', 'phone': '617-355-6225'}, {'name': 'Rachel Bernier', 'role': 'CONTACT', 'email': 'Rachel.Bernier@childrens.harvard.edu', 'phone': '857-218-5348'}], 'overallOfficials': [{'name': 'Viviane Nasr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': "Children's National Research Institute", 'class': 'OTHER'}, {'name': "Children's Hospital of The King's Daughters", 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Viviane Nasr', 'investigatorAffiliation': "Boston Children's Hospital"}}}}