Clinical trial NCT02155868: Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery
Official title: Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: Cerebral near-infrared spectroscopy monitoring
Postoperative complications
Cardiac surgery
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.


Eligibility criteria: Inclusion Criteria:

High-risk cardiac surgery patients as determined by at least one of the followings:

* 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:

* refusal of consent

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: Up to 30 day after randomisation
Secondary outcomes:
measure: Incidence of major organ morbidity and mortality
timeFrame: Up to 30 day after randomization
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
Other outcomes:
measure: Incidence of desaturation episodes
timeFrame: Intra operative
measure: Severity of desaturation episodes
timeFrame: Intra operative
Locations:
city: Novosibirsk
country: Russian Federation
facility: Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
state: Novosibirsk Territory
Study officials:
affiliation: Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
name: Vladimir V Lomivorotov, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.