Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Postoperative Complications Clinical Trial

Official title:

Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155868
• Other study ID #: NIRS-in-CS
• Status: Completed
• Phase: N/A
• First received: May 31, 2014
• Last updated: January 25, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• 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

Locations

Country	Name	City	State
Russian Federation	Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology	Novosibirsk	Novosibirsk Territory

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (6)

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. — View 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. — View Citation

Heringlake M, Garbers C, Käbler JH, Anderson I, Heinze H, Schön 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of desaturation episodes	Desaturation is defined as level of rSO2 less than 60%.	Intra operative
Other	Severity of desaturation episodes	Severity is defined as the product of length of time and depth of rSO2 less than 60%	Intra operative
Primary	Incidence of postoperative complications	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.	Up to 30 day after randomisation
Secondary	Incidence of major organ morbidity and mortality	This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death	Up to 30 day after randomization
Secondary	Duration of intensive care unit stay		Up to 30 day after randomization
Secondary	Duration of postoperative hospital stay		Up to 30 day after randomization
Secondary	Death from all causes at 30 days		Up to 30 day after randomisation