Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-16 @ 1:36 AM
Study NCT ID:
NCT03085420
Status:
TERMINATED
Last Update Posted:
2018-11-07
First Post:
2017-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of cardiac dysfunction in pediatric burn patients', 'timeFrame': 'Through study completion up to 4 years after hospital discharge.', 'description': 'Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Acute care hospital length of stay', 'timeFrame': 'Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).', 'description': 'Hospital length of stay (admission date to discharge date) will be compared between participants with cardiac dysfunction versus participants without cardiac dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Pediatrics', 'Cardiac Arrhythmia'], 'conditions': ['Cardiac Dysfunction']}, 'referencesModule': {'references': [{'pmid': '16819352', 'type': 'BACKGROUND', 'citation': 'Mak GZ, Hardy AR, Meyer RA, Kagan RJ. Reversible cardiomyopathy after severe burn injury. J Burn Care Res. 2006 Jul-Aug;27(4):482-6. doi: 10.1097/01.BCR.0000226018.30433.ED.'}, {'pmid': '23237822', 'type': 'BACKGROUND', 'citation': 'Howard TS, Hermann DG, McQuitty AL, Woodson LC, Kramer GC, Herndon DN, Ford PM, Kinsky MP. Burn-induced cardiac dysfunction increases length of stay in pediatric burn patients. J Burn Care Res. 2013 Jul-Aug;34(4):413-9. doi: 10.1097/BCR.0b013e3182685e11.'}, {'pmid': '26729111', 'type': 'BACKGROUND', 'citation': 'Guillory AN, Clayton RP, Herndon DN, Finnerty CC. Cardiovascular Dysfunction Following Burn Injury: What We Have Learned from Rat and Mouse Models. Int J Mol Sci. 2016 Jan 2;17(1):53. doi: 10.3390/ijms17010053.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.', 'detailedDescription': 'The investigators hope to learn the following:\n\n* If heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury.\n* The difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia.\n* A better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study.\n\nGroup 1 will consist of patients with ≥30% TBSA burn injury. Group 2 will consist of patients with \\<30% TBSA burn injury who develop a cardiac abnormality.\n\nExclusion Criteria:\n\nPatients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.'}, 'identificationModule': {'nctId': 'NCT03085420', 'briefTitle': 'Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient', 'orgStudyIdInfo': {'id': 'CIN1604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '≥30% TBSA burn injury', 'description': 'For patients in Group 1 with ≥30% TBSA, a baseline Echocardiogram (ECHO) will be obtained approximately one week from admission and monthly (+/- 1 week) or at an interval determined by cardiology during the acute inpatient stay. ECHO tests will be discontinued after 3 negative exams or when discontinued by cardiology, whichever comes first.', 'interventionNames': ['Diagnostic Test: Echocardiogram']}, {'type': 'NO_INTERVENTION', 'label': '<30% TBSA burn injury', 'description': 'For patients in Group 2 with \\<30% TBSA and presence of a cardiac abnormality standard clinical care appropriate for the type of arrhythmia will be followed.'}], 'interventions': [{'name': 'Echocardiogram', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ECHO'], 'description': 'A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.', 'armGroupLabels': ['≥30% TBSA burn injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Shriners Hospitals for Children', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Ivan Wilmot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospitals for Children'}, {'name': 'Petra M Warner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shriners Hospitals for Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ivan Wilmot', 'investigatorAffiliation': 'Shriners Hospitals for Children'}}}}