Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT02851433
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], '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'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of troponin', 'timeFrame': 'Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level'}]}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Heart surgery is a considerable source of stress for the myocardium that must be minimized.\n\nTroponin Ic is a reliable marker to determine the level of this myocardial stress.\n\nStudies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.\n\nThe aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided informed written consent.\n* Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).\n* Anterograde cardioplegia with cold blood\n\nExclusion Criteria:\n\n* Adults under guardianship.\n* Patients without national health insurance cover.\n* Epileptics.\n* Heart grafted patients.\n* Patients under 18 years and pregnant or beast-feeding women.\n* Aortic dissections and vascular surgery.\n* Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent\n* Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.\n* pre-operative LVEF\\<35%.\n* Coronary artery bypass graft alone or associated.\n* Mitral valve replacements.\n* Warm cardioplegia.'}, 'identificationModule': {'nctId': 'NCT02851433', 'acronym': 'SUPRA', 'briefTitle': 'Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'JAUDON-FAIVRE 2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane Group', 'interventionNames': ['Drug: total anaesthesia and postoperative inhaled sedation with Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol Group', 'interventionNames': ['Drug: total intravenous anaesthesia with Propofol.']}], 'interventions': [{'name': 'total anaesthesia and postoperative inhaled sedation with Sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Sevoflurane Group']}, {'name': 'total intravenous anaesthesia with Propofol.', 'type': 'DRUG', 'armGroupLabels': ['Propofol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}