Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-04 @ 7:51 PM
Study NCT ID:
NCT02846818
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Energy State in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017551', 'term': 'Microdialysis'}], 'ancestors': [{'id': 'D003956', 'term': 'Dialysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extracerebral microdialysis parameters', 'timeFrame': 'MD parameters were measured intraoperatively and for two hours postoperatively', 'description': 'Does the LP ratio of cerebral venous blood increase significantly during CPB indicating compromised cerebral oxidative metabolism.The analyses included the variables routinely monitored during intracerebral microdialysis: glucose, pyruvate, lactate, glutamate, glycerol and lactate to pyruvate ratio.'}], 'secondaryOutcomes': [{'measure': 'Mini mental state examination (MMSE)', 'timeFrame': 'Neurological complications with in 2 days after surgery', 'description': 'Patients were assessed preoperatively and postoperatively day two after surgery'}, {'measure': 'Near-infrared spectroscopy (NIRS)', 'timeFrame': 'one day', 'description': 'Right and left frontal rSO2 values were recorded simultaneously pre- and intraoperatively and for two hours postoperatively. Cerebral desaturation was defined as a decrease in the relative rSO2 value of 20 % compared with the individual pre-induction baseline value'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Microdialysis', 'Cardiac surgery', 'Lactate to pyruvate ratio', 'Cardiopulmonary bypass', 'Neurological complications'], 'conditions': ['Postoperative; Dysfunction Following Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '14674968', 'type': 'BACKGROUND', 'citation': 'Ahonen J, Salmenpera M. Brain injury after adult cardiac surgery. Acta Anaesthesiol Scand. 2004 Jan;48(1):4-19. doi: 10.1111/j.1399-6576.2004.00275.x.'}, {'pmid': '24703207', 'type': 'BACKGROUND', 'citation': 'McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB) during cardiac surgery. The aim of the present study is to investigate whether the lactate to pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a derangement of global cerebral energy state during cardiopulmonary bypass.', 'detailedDescription': 'Patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to usual range MAP (40 to 60 mmHg; n = 5) or intervention group MAP (60 to 80 mmHg; n = 5) during CPB. MD catheters were positioned in a retrograde direction in the internal jugular vein and a reference catheter was inserted into the brachial artery. The relations between LP ratio, MAP, data obtained from bi-frontal NIRS and neurological outcome measures were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Elective CABG on CPB\n\nExclusion criteria:\n\n* Acute patients or reoperations\n* Patients with epidural catheter\n* Previous stroke\n* Stenotic carotids\n* Ejection fraction (EF) \\< 50 %\n* Estimated per operative risk \\> 5%'}, 'identificationModule': {'nctId': 'NCT02846818', 'briefTitle': 'Cerebral Energy State in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Continuous Monitoring of Cerebral Energy State During Cardiac Surgery - A Novel Approach Utilizing Intravenous Microdialysis', 'orgStudyIdInfo': {'id': 'S-20130166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low mean arterial perfusion pressure', 'description': '5 patients undergoing primary, elective coronary artery bypass grafting were randomized to usual range MAP (40 to 60 mmHg) during CPB. Microdialysis catheters were positioned in a retrograde direction in the internal jugular vein.', 'interventionNames': ['Procedure: Microdialysis']}, {'type': 'EXPERIMENTAL', 'label': 'High mean arterial perfusion pressure', 'description': '5 patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to intervention group MAP (60 to 80 mmHg) during CPB. Microdialysis catheters were positioned in a retrograde direction in the internal jugular vein.', 'interventionNames': ['Procedure: Microdialysis']}], 'interventions': [{'name': 'Microdialysis', 'type': 'PROCEDURE', 'otherNames': ['MMSE', 'NIRS'], 'description': 'Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.', 'armGroupLabels': ['High mean arterial perfusion pressure', 'Low mean arterial perfusion pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Palle Toft, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Simon Mölström', 'investigatorAffiliation': 'Odense University Hospital'}}}}