Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-06 @ 6:59 PM
Study NCT ID:
NCT00624494
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2008-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2008-02-13', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': 'one month', 'description': 'Length of the hospital stays, Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['venous oxygen saturation', 'transpulmonary thermodilution'], 'conditions': ['Coronary Artery Disease', 'Hemodynamic Monitoring', 'Goal Directed Therapy']}, 'referencesModule': {'references': [{'pmid': '19183113', 'type': 'RESULT', 'citation': 'Smetkin AA, Kirov MY, Kuzkov VV, Lenkin AI, Eremeev AV, Slastilin VY, Borodin VV, Bjertnaes LJ. Single transpulmonary thermodilution and continuous monitoring of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand. 2009 Apr;53(4):505-14. doi: 10.1111/j.1399-6576.2008.01855.x. Epub 2009 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.', 'detailedDescription': 'At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Severe valve dysfunction or peripheral vascular disease\n* Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)\n* Transfer to CPB during surgery'}, 'identificationModule': {'nctId': 'NCT00624494', 'acronym': 'OPCAB', 'briefTitle': 'Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery', 'orgStudyIdInfo': {'id': '4347.07.2006'}, 'secondaryIdInfos': [{'id': 'Grant 4347.07.2006', 'type': 'OTHER', 'domain': 'HelseNord'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional monitoring', 'description': 'hemodynamic monitoring - conventional monitoring', 'interventionNames': ['Device: Conventional monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Advanced monitoring', 'description': 'hemodynamic monitoring - advanced monitoring', 'interventionNames': ['Device: Advanced monitoring']}], 'interventions': [{'name': 'Conventional monitoring', 'type': 'DEVICE', 'otherNames': ['Non actual'], 'description': 'In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)', 'armGroupLabels': ['Conventional monitoring']}, {'name': 'Advanced monitoring', 'type': 'DEVICE', 'otherNames': ['PiCCO-CeVOX'], 'description': 'In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.', 'armGroupLabels': ['Advanced monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163000', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Dep. of Anesthesiology, Northern SMU', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}], 'overallOfficials': [{'name': 'Mikhail Y Kirov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northern SMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. M.Y. Kirov, MD, PhD', 'investigatorFullName': 'Mikhail Y. Kirov', 'investigatorAffiliation': 'Northern State Medical University'}}}}