Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 11:00 PM
Study NCT ID:
NCT01450956
Status:
UNKNOWN
Last Update Posted:
2011-11-28
First Post:
2011-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-07', 'releaseDate': '2013-11-19'}, {'resetDate': '2014-08-19', 'releaseDate': '2014-08-18'}], 'estimatedResultsFirstSubmitDate': '2013-11-19'}}, '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': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-24', 'studyFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'within the first 30 days (plus or minus 3 days) after surgery', 'description': 'All cause mortality after the cardaic surgery, patients will be followed up for 30 days'}], 'secondaryOutcomes': [{'measure': 'serum cTnI concentrations', 'timeFrame': '48 h after the surgery', 'description': 'serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['congenital heart diseases', 'cardiopulmonary bypass', 'Pediatric', 'sevoflurane'], 'conditions': ['Congenital Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '26418205', 'type': 'DERIVED', 'citation': 'Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285.'}]}, 'descriptionModule': {'briefSummary': 'During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients (body weight \\< 10 kg)\n* diagnosed with congenital heart diseases\n* scheduled for repair operation with CPB\n* in the Department of Cardiovascular Surgery, Xijing Hospital\n\nExclusion Criteria:\n\n* systemic infections\n* other systemic diseases'}, 'identificationModule': {'nctId': 'NCT01450956', 'briefTitle': 'The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'XJXZ2011-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Patients will receive 2% sevoflurane via oxygenator during CPB', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will receive only oxygen and air through oxygenator', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane will be given at a concentration of 2% through oxygenator during CPB', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Patients will receive only oxygen and air through oxygenator', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenxiao Jin, PhD', 'role': 'CONTACT', 'email': 'jinzx10262@yahoo.com.cn', 'phone': '86-29-84771022'}, {'name': 'Hongyan Xiong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiovascular Surgery, Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhenxiao Jin, Ph.D', 'role': 'CONTACT', 'email': 'jinzx10262@yahoo.com.cn', 'phone': '86-29-84771022'}], 'overallOfficials': [{'name': 'Zhenxiao Jin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Surgery, Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-19', 'type': 'RELEASE'}, {'date': '2014-01-07', 'type': 'RESET'}, {'date': '2014-08-18', 'type': 'RELEASE'}, {'date': '2014-08-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xijing Hospital'}}}}