Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01839812
Status:
COMPLETED
Last Update Posted:
2014-06-16
First Post:
2013-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003366', 'term': 'Cosyntropin'}, {'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol level', 'timeFrame': '24 hours after surgery', 'description': 'Primary outcome measure is the cortisol level for each patient at 7 time points throughout the operation and first 24 post-operative hours. Dexamethasone level of the patient is compared with the cortisol level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'Cortisol', 'Dexamethasone'], 'conditions': ['Adrenal Cortex Diseases', 'Infant Morbidity']}, 'descriptionModule': {'briefSummary': 'Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.', 'detailedDescription': 'We conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery.\n\nBlood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-CPB/pre-MUF, 3) Intensive care unit (ICU) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. At each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, ACTH, Interleukin (IL) 10, IL 8, and IL 6. In addition, the innate stress response was evaluated with a cosyntropin stimulation test. Each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), ICU arrival (time 3), and 24 hours after ICU arrival (time 7). Cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '365 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less than 365 days of age\n* Congenital cardiac surgery that requires cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Corticosteroids within 24 hours prior to enrollment\n* Less than 36 weeks gestational age at time of surgery\n* pre-operative mechanical circulatory support (ECMO)'}, 'identificationModule': {'nctId': 'NCT01839812', 'briefTitle': 'Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery', 'orgStudyIdInfo': {'id': '08-001638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cosyntropin stimulation test', 'description': 'All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response.', 'interventionNames': ['Drug: Cosyntropin']}], 'interventions': [{'name': 'Cosyntropin', 'type': 'DRUG', 'otherNames': ['adrenocorticotropic hormone'], 'description': 'A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.', 'armGroupLabels': ['cosyntropin stimulation test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55903', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Sheri S Crow, MD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Sheri Crow, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}