Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-31 @ 11:09 AM
Study NCT ID:
NCT00556361
Status:
COMPLETED
Last Update Posted:
2007-11-12
First Post:
2007-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006345', 'term': 'Heart Septal Defects, Ventricular'}], 'ancestors': [{'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-09', 'studyFirstSubmitDate': '2007-11-09', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare expression of serum markers of CNS injury', 'timeFrame': 'within 48 hours'}, {'measure': 'to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.', 'timeFrame': 'within 48 hours'}], 'secondaryOutcomes': [{'measure': 'to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls', 'timeFrame': 'one month'}]}, 'conditionsModule': {'conditions': ['Ventricular Septal Defect']}, 'referencesModule': {'references': [{'pmid': '21926656', 'type': 'DERIVED', 'citation': 'Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.'}]}, 'descriptionModule': {'briefSummary': 'To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less than one year of age\n* undergoing cardiac surgery for repair of ventricular septal defect\n* requiring cardiopulmonary bypass\n* not requiring retrogrades cerebral perfusion\n\nExclusion Criteria:\n\n* Downs Syndrome'}, 'identificationModule': {'nctId': 'NCT00556361', 'briefTitle': 'Use of Ketamine Prior to Cardiopulmonary Bypass in Children', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Use of Ketamine Prior to Cardiopulmonary Bypass in Children', 'orgStudyIdInfo': {'id': '28781 Bhutta'}, 'secondaryIdInfos': [{'id': 'CUMG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: saline']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: ketamine']}], 'interventions': [{'name': 'saline', 'type': 'DRUG', 'description': '2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass', 'armGroupLabels': ['1']}, {'name': 'ketamine', 'type': 'DRUG', 'description': '2 mg/Kg IV within 5 minutes of cardiopulmonary bypass', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Adnan T Bhutta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Hospital Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}}}}