Postoperative Complications
Conditions
Keywords
Cerebral near-infrared spectroscopy monitoring, Postoperative complications, Cardiac surgery
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.
Interventions
OTHERCorrection 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.
OTHERStandard treatment
Standard treatment
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications | Up to 30 day after randomisation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major organ morbidity and mortality | Up to 30 day after randomization | This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of desaturation episodes | Intra operative | Desaturation is defined as level of rSO2 less than 60%. |
| Severity of desaturation episodes | Intra operative | Severity is defined as the product of length of time and depth of rSO2 less than 60% |
Countries
Russia
Outcome results
None listed