Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
NCT ID: NCT02155868
Last Updated: 2017-01-26
Study Results
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Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Hypothesis 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C.
Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it.
Correction rSO2 desaturation.
Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it.
In case of rSO2 decrease less than 60% correct:
head 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.
Control
Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.
Standard treatment
Standard treatment
Interventions
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Correction rSO2 desaturation.
Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it.
In case of rSO2 decrease less than 60% correct:
head 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.
Standard treatment
Standard treatment
Eligibility Criteria
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Inclusion Criteria
* the age greater than or equal to 75 years on the day of screening;
* left ventricle ejection fraction less than 35%;
* use of a preoperative intraaortic balloon pump;
* 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)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Evgeny Fominskiy, MD, PhD
Mr
Principal Investigators
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Vladimir V Lomivorotov, Prof
Role: PRINCIPAL_INVESTIGATOR
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Locations
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Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, Russia
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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NIRS-in-CS
Identifier Type: -
Identifier Source: org_study_id
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