Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT07163858
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-site, prospective, interventional, single-blind randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess use of noradrenaline in the experimental group (postural mobilization) vs control group (NA only) for hemodynamic management during open-heart coronary bypass graft surgery.', 'timeFrame': 'From beginning to end of urgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['open-heart coronary bypass', 'passive leg raising', 'hemodynamic management', 'off-pump CABG surgery'], 'conditions': ['Coronary Artery Disease With Need for Bypass Surgery', 'Coronary Artery Disease(CAD)', 'Coronary Artery Bypass', 'Off Pump Coronary Artery Bypass Graft', 'Off Pump Coronary Artery Bypass Surgery', 'Hemodynamic Management', 'Hemodynamic Optimization', 'Noradrenaline']}, 'descriptionModule': {'briefSummary': 'This interventional prospective randomized study is designed to compare hemodynamic management using postural mobilization (+/- noradrenaline) versus noradrenaline only in patients undergoing open-heart coronary artery bypass graft (CABG) surgery.', 'detailedDescription': 'OPTICAB is a single-site study in France that aims to compare two hemodynamic management techniques during off-pump coronary artery bypass graft (CABG) surgery: postural mobilization (+/- noradrenaline) versus noradrenaline only. Primary objective is to evaluate how often noradrenaline is needed when managing hemodynamics using postural mobilization (passive leg raising) during off-pump CABG surgery. The study will also compare revascularization rate and post-operative complications among both groups, and assess perioperative hemodynamic management during the 30-day follow up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* patient requiring isolated coronary bypass surgery\n* Elective procedure or medical emergency\n* First cardiac surgery\n* Patient with an EF ≥30%\n* Mandatory affiliation to a social security system\n* Signed informed consent form\n* Suspension of renin-angiotensin system inhibitors and angiontensn-neprilysin receptor blockers and sartans the day before surgical procedure\n\nExclusion Criteria:\n\n* Contraindication to an inotropic substance (only NA will be used)\n* Contraindication to passive leg raising\n* Patient in a life-threatening emergency\n* History of cardiac surgery\n* Bilateral iliac or common femoral artery occlusion\n* EF \\< 30%\n* Pregnancy and breastfeeding\n* Renal failure (GFR \\< 40 ml/min/1.73 m²)\n* Patient with bilateral thigh amputation\n* Class III obesity BMI \\> 40 kg/m²'}, 'identificationModule': {'nctId': 'NCT07163858', 'acronym': 'OPTICAB', 'briefTitle': 'Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Infirmerie Protestante de Lyon'}, 'officialTitle': 'Comparison of Hemodynamic Management by Postural Mobilization Versus Chemical Vasoconstriction Using Noradrenaline Exclusively in Off-pump Coronary Artery Bypass Graft Surgery: A Prospective, Randomized, Comparative, Single-center Study.', 'orgStudyIdInfo': {'id': 'IPL/01-2024'}, 'secondaryIdInfos': [{'id': 'ID-RCB: 2024-A00683-44', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline)', 'description': 'In order to manage hemodynamics, postural mobilization will be applied by raising legs passively up to a 45° angle prior to any drug use (noradrenaline). If passive leg raising is not sufficient, noradrenaline will be used to stabilize hemodynamics,.', 'interventionNames': ['Procedure: passive leg raising for hemodynamic management during open-heart coronary bypass grafting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: use of noradrenaline only (no postural mobilization)', 'description': 'Noradrenaline will be used to manage hemodynamics. Passive leg raising will not be used in this group', 'interventionNames': ['Procedure: Use of Noradrenaline only in control group']}], 'interventions': [{'name': 'passive leg raising for hemodynamic management during open-heart coronary bypass grafting', 'type': 'PROCEDURE', 'description': 'Passive leg raising will be used in the experimental group in order to manage hemodynamics: legs will be raised to an angle of approx. 45°', 'armGroupLabels': ['Postural Group: hemodynamic management using postural mobilization (+/- noradrenaline)']}, {'name': 'Use of Noradrenaline only in control group', 'type': 'PROCEDURE', 'description': 'Noradrenaline will be used for hemodynamic management. Passive leg raising will not be used in this group', 'armGroupLabels': ['Control group: use of noradrenaline only (no postural mobilization)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69300', 'city': 'Caluire-et-Cuire', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Infirmerie Protestante de Lyon', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}], 'centralContacts': [{'name': 'SIESS', 'role': 'CONTACT', 'email': 'recherche-clinique@infirmerie-protestante.com', 'phone': '+33 426297927'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A plan has not yet been decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infirmerie Protestante de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}