Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT04244435
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroaxial Prophylaxis for CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054059', 'term': 'Coronary Occlusion'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-19', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospital mortality', 'timeFrame': '1 year'}, {'measure': 'Hospitalization duration', 'timeFrame': '1 year'}, {'measure': 'Duration of treatment in the intensive care unit', 'timeFrame': 'up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery bypass grafting', 'prevention of complication', 'neuroaxial prophylaxis', 'thoracic epidural analgesia'], 'conditions': ['Coronary Artery Occlusion']}, 'descriptionModule': {'briefSummary': 'Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.', 'detailedDescription': 'Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary artery bypass grafting\n\nExclusion Criteria:\n\n* Absolute contraindications for the use of thoracic epidural analgesia'}, 'identificationModule': {'nctId': 'NCT04244435', 'briefTitle': 'Neuroaxial Prophylaxis for CABG', 'organization': {'class': 'OTHER', 'fullName': 'Volgograd State Medical University'}, 'officialTitle': 'Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'TEA-CABG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic epidural analgesia', 'description': 'CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period', 'interventionNames': ['Procedure: CABG', 'Drug: thoracic epidural analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioids', 'description': 'CABG and opioids will be used for perioperative analgesia', 'interventionNames': ['Procedure: CABG', 'Drug: analgesia of opioids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CABG', 'description': 'coronary artery bypass grafting with and without cardiopulmonary bypass', 'interventionNames': ['Procedure: CABG']}], 'interventions': [{'name': 'CABG', 'type': 'PROCEDURE', 'description': 'coronary artery bypass grafting with and without cardiopulmonary bypass', 'armGroupLabels': ['CABG', 'Opioids', 'Thoracic epidural analgesia']}, {'name': 'thoracic epidural analgesia', 'type': 'DRUG', 'description': 'thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)', 'armGroupLabels': ['Thoracic epidural analgesia']}, {'name': 'analgesia of opioids', 'type': 'DRUG', 'description': 'Opioids will be used for perioperative analgesia', 'armGroupLabels': ['Opioids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400079', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Hospital №1 of Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Volgograd State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Mikhail I Turovets, MD', 'investigatorAffiliation': 'Volgograd State Medical University'}}}}