Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT00850720
Status:
TERMINATED
Last Update Posted:
2014-01-07
First Post:
2009-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D013972', 'term': 'Thyrotropin'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kiran.hebbar@choa.org', 'phone': '404-785-1600', 'title': 'Kiran Hebbar, MBBS', 'organization': "Children's Healthcare of Atlanta"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination of study; Technical problems with measurement leading to unreliable or uninterpretable data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cardiac Surgery', 'description': 'Infants with congenital defects.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'NO Outcomes - Study Terminated Without Data.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Surgery', 'description': 'Infants with congenital defects.'}], 'timeFrame': 'Study terminated - no data.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Surgery', 'description': 'Infants with congenital defects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Surgery', 'description': 'Infants with congenital defects.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female'}, {'title': 'Male'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Inability to recruit / logistic problems.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2009-02-24', 'resultsFirstSubmitDate': '2010-01-15', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-18', 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NO Outcomes - Study Terminated Without Data.', 'timeFrame': 'Study terminated - no data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biological Response Modifiers', 'Bypass Surgery', 'Cardiology', 'Congenital Heart Disease', 'Endocrinology', 'Hormone Dysfunction', 'Hormones', 'Neuroendocrinology', 'Pediatric Surgery'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at Childrens Healthcare of Atlanta at Egleston', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.\n* Subject must have arterial or central venous lines to be enrolled.\n* Subject must have a documented weight of 2.5 Kilograms or greater.\n* Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.\n\nExclusion Criteria:\n\n* Medical urgency preventing timely administration of the consenting process.\n* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.\n* Have given steroids intravenously (IV) or oral steroids within the last month.\n* Have a preexisting neuroendocrine disorder.\n* Have been treated with antipsychotic medication.\n* Have human immunodeficiency virus (HIV).\n* Have received etomidate for intubation.\n* Other technical considerations that would prevent acquisition of sufficient samples OR inability / unwillingness of the legal guardian to provide consent."}, 'identificationModule': {'nctId': 'NCT00850720', 'briefTitle': 'Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient', 'orgStudyIdInfo': {'id': 'IRB00007443'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgery', 'description': 'Infants with congenital defects.', 'interventionNames': ['Other: Blood draws']}], 'interventions': [{'name': 'Blood draws', 'type': 'OTHER', 'otherNames': ['Tests being analyzed:', '• Cortisol', '• Vasopressin (ADH)', '• Cortisol Free', '• Thyroid Stimulating Hormone (TSH)', '• Free Thyroxine(FT4)'], 'description': 'Samples of blood to be drawn before surgery, and nine hours after surgery.', 'armGroupLabels': ['Cardiac Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta at Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Kiran Hebbar, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Emory University & Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - CT', 'investigatorFullName': 'Kiran Hebbar', 'investigatorAffiliation': 'Emory University'}}}}