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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, Russia
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.
Time frame: Up to 30 day after randomisation
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
Time frame: Up to 30 day after randomization
Duration of intensive care unit stay
Time frame: Up to 30 day after randomization
Duration of postoperative hospital stay
Time frame: Up to 30 day after randomization
Death from all causes at 30 days
Time frame: Up to 30 day after randomisation
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