Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-25 @ 10:36 PM
Study NCT ID:
NCT03102359
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2017-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-25', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative minimal hepatic encephalopathy (MHE)', 'timeFrame': '14 days after surgery', 'description': 'Using PSE-Syndrom-Test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.\n* Sign the informed consent\n\nExclusion Criteria:\n\n* The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.\n* Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.\n* With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.\n* Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.'}, 'identificationModule': {'nctId': 'NCT03102359', 'briefTitle': 'Brain Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation', 'orgStudyIdInfo': {'id': 'TJ-IRB20170201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective Head Cooling', 'description': 'Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery.', 'interventionNames': ['Device: Cooling Helmet']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Selective Head Cooling and Dexmedetomidine', 'description': 'Using selective head cooling combined with dexmedetomidine as described before', 'interventionNames': ['Drug: Dexmedetomidine', 'Device: Cooling Helmet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention in this group'}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery', 'armGroupLabels': ['Dexmedetomidine', 'Selective Head Cooling and Dexmedetomidine']}, {'name': 'Cooling Helmet', 'type': 'DEVICE', 'description': 'Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group', 'armGroupLabels': ['Selective Head Cooling', 'Selective Head Cooling and Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430040', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, postgraduate', 'role': 'CONTACT', 'email': '535413900@qq.com', 'phone': '18627752156'}], 'facility': 'Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Ailin Luo, doctorate', 'role': 'CONTACT', 'email': 'alluo@tjh.tjmu.edu.cn', 'phone': '13507122565'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate', 'investigatorFullName': 'Huawei He', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}