Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT06757868
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amobarbital and Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000654', 'term': 'Amobarbital'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac recurrence time', 'timeFrame': '1 hour after heart beat recurrence', 'description': 'Stop extracorporeal circulation until heart beat time'}], 'secondaryOutcomes': [{'measure': 'extubation time', 'timeFrame': '1day', 'description': 'time from stopping anesthetics to extubation'}, {'measure': 'cTnI', 'timeFrame': '2 days', 'description': 'Using enzyme-linked immunosorbent assay (ELISA) to detect serum cardiac troponin I (cTnI) in patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'Explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.', 'detailedDescription': 'AMO is a short acting complex I blocker that blocks mitochondrial complex I between flavoprotein and ubiquitin, and its blocking effect can be rapidly reversed. Our study is to explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-65 years old, undergo elective cardiac surgery with extracorporeal circulation.\n* ASA II-III;\n* surgical duration is 3-6 hours;\n* Sign the informed consent form\n\nExclusion Criteria:\n\n* BMI less than 18 kg/m2 or greater than 30 kg/m2;\n* Individuals with a history or potential history of drug abuse or alcohol dependence;\n* Preoperative use of sedatives or analgesics;\n* Individuals with severe liver and kidney dysfunction;\n* Individuals who are allergic or potentially allergic to barbiturates;\n* Patients with coagulation dysfunction, endocrine disorders, or other conditions that affect hemodynamic status;\n* Participated in other clinical studies in the past 3 months;\n* The researchers believe that participants who are not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06757868', 'briefTitle': 'Amobarbital and Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'AMOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amo group', 'description': 'amobarbital 1mg/kg is given prior to cardiopulmonary bypass', 'interventionNames': ['Drug: Amobarbital']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mida group', 'description': 'midazolam 0.1mg/kg is given prior to cardiopulmonary bypass', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Amobarbital', 'type': 'DRUG', 'otherNames': ['AMO'], 'description': 'Amobarbital 1mg/kg is given prior to cardiopulmonary bypass', 'armGroupLabels': ['Amo group']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['MIDA'], 'description': 'midazolam 0.1mg/kg is given prior to cardiopulmonary bypass', 'armGroupLabels': ['Mida group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'aijun Xu, Dr.', 'role': 'CONTACT', 'email': 'ajxu@tjh.tjmu.edu.cn', 'phone': '86-27-83663173'}, {'name': 'aihua Du, Dr.', 'role': 'CONTACT', 'email': '70663307@qq.com', 'phone': '02783663625'}], 'facility': 'Tongji hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'mujun chang, Dr', 'role': 'CONTACT', 'email': 'changmujun@hotmail.com', 'phone': '+862783663625'}, {'name': 'Pu zhou, Dr', 'role': 'CONTACT', 'email': 'tongjihlunli@163.com', 'phone': '+862783663625'}], 'overallOfficials': [{'name': 'Aihua Du, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'aijun xu', 'investigatorAffiliation': 'Tongji Hospital'}}}}