Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02185118
Status:
UNKNOWN
Last Update Posted:
2014-07-09
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-06', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-07-06', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subcellular location of Nuclear Factor-KAPPA B p65 subunit', 'timeFrame': 'within 10 hours after the intervention'}], 'secondaryOutcomes': [{'measure': 'tumor necrosis factor-alpha', 'timeFrame': 'within 10 hours after the intervention'}, {'measure': 'interleukin- 1 beta', 'timeFrame': 'within 10 hours after the intervention'}, {'measure': 'interleukin 6', 'timeFrame': 'within 10 hours after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Sepsis is a major cause of death in intensive care units. Despite the investigators improved understanding, which has reduced the risk of dying with sepsis, the number of people who die each year continues to increase due to an overall increase in the number of cases.In our previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line against in-vitro sepsis induced by lipopolysaccharide (LPS).\n\nIn this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis induced by LPS or plasma from septic patients.', 'detailedDescription': '100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant after stimulation of LPS or plasma from septic patients, and also inhibit the nuclear location of nuclear factor-kappa B p65 subunit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Human PBMCs were only isolated from the adult patients without sepsis/SIRS/infectious diseases.\n* The plasma for induction of clinical in-vitro sepsis, was only isolated from adult patients with sepsis.\n\nExclusion Criteria:\n\n* Patients who had been selected for other clinical trials in the 3 months before.'}, 'identificationModule': {'nctId': 'NCT02185118', 'briefTitle': 'Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'In-vitro Experimental Study About Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Sepsis', 'orgStudyIdInfo': {'id': 'NSFC-81171839'}, 'secondaryIdInfos': [{'id': 'Chinese NSFC', 'type': 'OTHER_GRANT', 'domain': '30672041, 81171839 to Lichao Hou'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxygen plus isoflurane/sevoflurane', 'description': 'All human peripheral blood mononuclear cells (PBMCs) were from patients with non sepsis/non SIRS/non infection.\n\nThe above cells were treated with oxygen or oxygen plus isoflurane/sevoflurane after stimulation of lipopolysaccharide/plasma from septic patients.', 'interventionNames': ['Drug: oxygen', 'Drug: Sevoflurane', 'Drug: Isoflurane']}], 'interventions': [{'name': 'oxygen', 'type': 'DRUG', 'otherNames': ['100% oxygen'], 'description': '1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.\n2. Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.', 'armGroupLabels': ['oxygen plus isoflurane/sevoflurane']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['subanesthetic sevoflurane in 60% oxygen'], 'description': '1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.\n2. Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.', 'armGroupLabels': ['oxygen plus isoflurane/sevoflurane']}, {'name': 'Isoflurane', 'type': 'DRUG', 'otherNames': ['subanesthetic isoflurane in 60% oxygen'], 'description': '1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.\n2. Treatment of 100% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.', 'armGroupLabels': ['oxygen plus isoflurane/sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lichao Hou', 'role': 'CONTACT', 'email': 'hou2001@fmmu.edu.cn'}], 'facility': 'Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Lichao Hou, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'hou2001@fmmu.edu.cn'}], 'overallOfficials': [{'name': 'Lichao Hou, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D', 'investigatorFullName': 'Lichao Hou', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}