Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: Correction rSO2 desaturation.
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Correction rSO2 desaturation.<br>* 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.<br>|
| Placebo Comparator: Control<br>Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it. | Other: Standard treatment<br>* Standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of intensive care unit stay |  | Up to 30 day after randomization | 
| Duration of postoperative hospital stay |  | Up to 30 day after randomization | 
| Death from all causes at 30 days |  | Up to 30 day after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral near-infrared spectroscopy monitoring, Postoperative complications, Cardiac surgery