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Comparison of cerebral tissue oxygen desaturation in patients undergoing on-pump or off-pump coronary artery bypass grafting

Comparison of cerebral tissue oxygen desaturation in patients undergoing on-pump or off-pump coronary artery bypass grafting - Tissue oxygenation during heart surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38255
Enrollment
60
Registered
2011-04-19
Start date
2011-06-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease coronary atherosclerosis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)