Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT02155868
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2014-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2014-05-31', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of desaturation episodes', 'timeFrame': 'Intra operative', 'description': 'Desaturation is defined as level of rSO2 less than 60%.'}, {'measure': 'Severity of desaturation episodes', 'timeFrame': 'Intra operative', 'description': 'Severity is defined as the product of length of time and depth of rSO2 less than 60%'}], 'primaryOutcomes': [{'measure': 'Incidence of postoperative complications', 'timeFrame': 'Up to 30 day after randomisation', 'description': 'This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.'}], 'secondaryOutcomes': [{'measure': 'Incidence of major organ morbidity and mortality', 'timeFrame': 'Up to 30 day after randomization', 'description': 'This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death'}, {'measure': 'Duration of intensive care unit stay', 'timeFrame': 'Up to 30 day after randomization'}, {'measure': 'Duration of postoperative hospital stay', 'timeFrame': 'Up to 30 day after randomization'}, {'measure': 'Death from all causes at 30 days', 'timeFrame': 'Up to 30 day after randomisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral near-infrared spectroscopy monitoring', 'Postoperative complications', 'Cardiac surgery'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '17179242', 'type': 'BACKGROUND', 'citation': 'Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.'}, {'pmid': '15578464', 'type': 'BACKGROUND', 'citation': 'Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.'}, {'pmid': '19101265', 'type': 'BACKGROUND', 'citation': 'Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.'}, {'pmid': '20579669', 'type': 'BACKGROUND', 'citation': 'Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.'}, {'pmid': '21178669', 'type': 'BACKGROUND', 'citation': 'Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.'}, {'pmid': '18270192', 'type': 'BACKGROUND', 'citation': 'Denault A, Deschamps A, Murkin JM. A proposed algorithm for the intraoperative use of cerebral near-infrared spectroscopy. Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):274-81. doi: 10.1177/1089253207311685.'}]}, 'descriptionModule': {'briefSummary': 'Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.\n\nHypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHigh-risk cardiac surgery patients as determined by at least one of the followings:\n\n* the age greater than or equal to 75 years on the day of screening;\n* left ventricle ejection fraction less than 35%;\n* use of a preoperative intraaortic balloon pump;\n* combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance \\< 60 ml/min)\n\nExclusion Criteria:\n\n* refusal of consent'}, 'identificationModule': {'nctId': 'NCT02155868', 'briefTitle': 'Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study', 'orgStudyIdInfo': {'id': 'NIRS-in-CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C.\n\nPredefined protocol of interventions for correcting rSO2 desaturation (\\< 60%) during cardiac surgery and the first six hours after it.', 'interventionNames': ['Other: Correction rSO2 desaturation.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Correction rSO2 desaturation.', 'type': 'OTHER', 'description': 'Predefined protocol of interventions for correcting rSO2 desaturation (\\< 60%) during cardiac surgery and the first six hours after it.\n\nIn case of rSO2 decrease less than 60% correct:\n\nhead position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood \\< 35 mmHg; mean arterial pressure \\< 60 mmHg; central venous pressure \\> 10 mmHg; cardiac index \\< 2.0 l/min/m2; mixed venous oxygen saturation \\< 60%; hemoglobin \\< 65 g/L during cardiopulmonary bypass or hemoglobin \\< 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption.', 'armGroupLabels': ['Intervention']}, {'name': 'Standard treatment', 'type': 'OTHER', 'description': 'Standard treatment', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'state': 'Novosibirsk Territory', 'country': 'Russia', 'facility': 'Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Vladimir V Lomivorotov, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Evgeny Fominskiy, MD, PhD', 'investigatorAffiliation': 'Meshalkin Research Institute of Pathology of Circulation'}}}}