Comparison of cerebral tissue oxygen desaturation in patients undergoing on-pump or off-pump coronary artery bypass grafting
Completed
- Conditions
- 1000984110007593coronary artery diseasecoronary atherosclerosis10011082
- Registration Number
- NL-OMON38255
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age >=18 years
Informed patient consent
Coronary artery disease suitable for both on-pump and off-pump CABG surgery.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the incidence of significant brain tissue<br /><br>oxygen desaturation, defined as AUC40 (area under the curve, area above the<br /><br>saturation curve and below the 40% upper limit) of > 600 %.sec, a function of<br /><br>both duration (in seconds) and severity (% < 40) of desaturation. This cut-off<br /><br>value was found to be predictive of postoperative cognitive dysfunction in a<br /><br>previous study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Baseline cerebral StO2<br /><br>• Change in baseline cerebral StO2 after breathing 100% O2 for 5 mins<br /><br>• Thenar muscle and renal StO2<br /><br>• Other metrics of cerebral, renal and thenar muscle tissue oxygen desaturation<br /><br>(calculated from the trend in StO2 over time) such as lowest recorded SctO2,<br /><br>AUC50<br /><br>• Incidence of postoperative cognitive dysfunction (defined as a combined<br /><br>Z-score for all tests >2 or a Z-score >2 in >2 individual tests)<br /><br>• Plasma concentrations of biomarkers of inflammation and neurological injury:<br /><br>IL-6, TNF-a, NSE and carnosinase<br /><br>• Urine concentration of biomarkers of acute renal injury: KIM-1 and NGAL.<br /><br>• Plasma creatinine; incidence of renal failure </p><br>