coronary artery disease coronary atherosclerosis
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age >=18 years Informed patient consent Coronary artery disease suitable for both on-pump and off-pump CABG surgery.
Exclusion criteria
Exclusion criteria: History of head trauma or stroke causing significant active neurologic disease History of neurosurgery Severe or symptomatic carotid artery disease Requirement for valve surgery in addition to CABG Pre-existing acute or chronic renal dysfunction Urgent or emergency surgery Difficulty with cognitive testing: impaired hearing or eyesight, poor Dutch language comprehension, disability impairing the usage of the hand or arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the incidence of significant brain tissue oxygen desaturation, defined as AUC40 (area under the curve, area above the saturation curve and below the 40% upper limit) of > 600 %.sec, a function of both duration (in seconds) and severity (% | — |
Secondary
| Measure | Time frame |
|---|---|
| • Baseline cerebral StO2 • Change in baseline cerebral StO2 after breathing 100% O2 for 5 mins • Thenar muscle and renal StO2 • Other metrics of cerebral, renal and thenar muscle tissue oxygen desaturation (calculated from the trend in StO2 over time) such as lowest recorded SctO2, AUC50 • Incidence of postoperative cognitive dysfunction (defined as a combined Z-score for all tests >2 or a Z-score >2 in >2 individual tests) • Plasma concentrations of biomarkers of inflammation and neurological injury: IL-6, TNF-a, NSE and carnosinase • Urine concentration of biomarkers of acute renal injury: KIM-1 and NGAL. • Plasma creatinine; incidence of renal failure | — |
Countries
Netherlands