Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT00577434
Status:
TERMINATED
Last Update Posted:
2015-03-12
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'Sluggish enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Procedural sedation', 'Sedation for diagnostic imaging'], 'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'This medication is used for procedural sedation and sedation for diagnostic imaging. The purpose of this study is to find out what happens to pentobarbital in the body after it is given to children who have had heart surgery.', 'detailedDescription': 'This clinical trial of pentobarbital admistered as a bolus dose for procedural or imaging seddation will determine the PK of the drug in neonates, infants,, and children who are postoperative from cardiac surgery. Pediatric patients hsopitalized in the CICU who would receive IV bolus doses of pentobarbital as standard of care are eligible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients enrolled in this study will be postoperative from cardiac surgery adn have require sedation for a procedure or diagnostic imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Will receive intravenous pentobarbital for procedural/imaging sedation as standard of care\n* Age(Neonates, Young Infants, Older Infants, and Children Up to 6 years old)\n* Diagnosis either postop from cardiac surgery or requrie sedation with IV pentobarbital as standard of care\n* Adequate liver function tests\n* Informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.'}, 'identificationModule': {'nctId': 'NCT00577434', 'briefTitle': 'Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'The Pharmacokinetics and Pharmacodynamics of a Single Dose of Pentobarbital for Clinically Indicated Sedation for Neonates, Infants, and Children Recovering From Open Heart Surgery', 'orgStudyIdInfo': {'id': '2006-4-4822'}, 'secondaryIdInfos': [{'id': 'CTRC 2012'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Athena Zuppa, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}