Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-21 @ 12:57 PM
Study NCT ID:
NCT03013634
Status:
UNKNOWN
Last Update Posted:
2017-01-06
First Post:
2016-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': 'through study completion, an average of 5 days'}, {'measure': 'length of stay', 'timeFrame': 'through study completion, an average of 6 weeks', 'description': 'from date of admission to discharge time'}], 'primaryOutcomes': [{'measure': 'Peri-operative mortality', 'timeFrame': 'through study completion, an average of 5 weeks'}, {'measure': 'The incidence of cardiac complications', 'timeFrame': 'from anesthesia induction to 24 hours after operation'}], 'secondaryOutcomes': [{'measure': 'Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence', 'timeFrame': 'before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation', 'description': 'myohemoglobin,creatine kinase isoenzyme,cardiac troponinâ… ,Heart-type fatty acid-binding protein'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dexmedetomidine'], 'conditions': ['Evidence of Liver Transplantation', 'Myocardial Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation', 'detailedDescription': 'Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Some investigations indicated that dexmedetomidine was able to protect the myocardium via improving the activity of Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of dexmedetomidine on myocardial injury during liver transplantation remain unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital\n\nExclusion Criteria:\n\n* Pre-existing respiratory failure,renal failure,hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT03013634', 'briefTitle': 'Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin First Central Hospital'}, 'orgStudyIdInfo': {'id': 'TianjinFCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine Group', 'description': 'Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline Group', 'description': 'Equal volume normal saline substitute for dexmedetomidine', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.', 'armGroupLabels': ['Dexmedetomidine Group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Equal volume normal saline substitute for dexmedetomidine', 'armGroupLabels': ['Normal saline Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300192', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenli Yu, PhD', 'role': 'CONTACT', 'email': 'yzxyuwenli@163.com', 'phone': '86-13920098326'}], 'facility': 'No.24 Fukang Road,Nankai District', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wenli Yu, PhD', 'role': 'CONTACT', 'email': 'yzxyuwenli@163.com', 'phone': '86-13920098326'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital', 'investigatorFullName': 'Wenli Yu', 'investigatorAffiliation': 'Tianjin First Central Hospital'}}}}