The goal of this study is to determine if off-pump CABG surgery is associated with better cerebral tissue oxygenation when compared with on-pump CABG. In addition, we would like to compare the results of two different monitors of brain tissue…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cognitive and attention disorders and disturbances
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 (% < 40) of desaturation. This cut-off
value was found to be predictive of postoperative cognitive dysfunction in a
previous study.
Secondary outcome
• 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-α, NSE and carnosinase
• Urine concentration of biomarkers of acute renal injury: KIM-1 and NGAL.
• Plasma creatinine; incidence of renal failure
Background summary
Coronary artery bypass grafting (CABG) is currently the preferred treatment for
disease of the coronary artery main stem or of multiple coronary vessel
disease, but is often associated with complications, including post-operative
cognitive dysfunction and impaired renal function. For a long time it was
assumed that these complications were caused by impaired tissue oxygenation
(StO2) caused by the physiological alterations associated with cardiopulmonary
bypass (CPB). For this and other reasons the technique of *off-pump* CABG
surgery was developed, in which the grafts are implanted with the heart beating
and no artificial circulation through the CPB machine, with the aim of
preventing these physiological derangements, and thereby reducing the incidence
of mortality and major complications. Recent studies have however failed to
show long-term benefits of off-pump surgery, but with regard to renal function
and POCD they have used insensitive and controversial methods that may have
been unable to detect fine differences. Recently it has become possible to
measure tissue oxygenation (StO2) non-invasively using commercially available
monitors that use near infra-red spectroscopy (NIRS) to assess tissue oxygen
levels. The levels are physiologically highly relevant since they reflect the
overall balance between blood flow, blood oxygen content, and tissue oxygen
uptake and requirements. The aim of this study is to use NIRS monitors to
determine if there is a difference in cerebral, renal and peripheral tissue
oxygenation between on- and off-pump CABG surgery.
Study objective
The goal of this study is to determine if off-pump CABG surgery is associated
with better cerebral tissue oxygenation when compared with on-pump CABG. In
addition, we would like to compare the results of two different monitors of
brain tissue oxygenation with each other, and assess the correlation between
brain tissue oxygenation and oxygenation measurements in renal and muscular
tissue, as well as with conventional hemodynamic and metabolic variables, such
as central venous oxygen saturation (ScvO2). Finally, we aim to determine if
duration and extent of cerebral oxygen desaturation predicts outcome variables
such as postoperative cognitive performance.
Study design
Prospective, randomised, observational trial.
Study burden and risks
Besides the randomisation to either on-pump or off-pump surgery, no
interventions will be performed. Only patients who are eligible for both
surgical techniques are included and randomised.
Due to the observational character of this study and the non-invasive
measurements, the risks involved are negligible. In addition to standard care,
4 sensors will be noninvasively attached to the skin by using adhesive
plasters. Theoretically, patients could potentially be allergic to this
adhesive and will be asked for any previous events during the visitation on the
ward. If a patient is indeed allergic to the type of sticker that will be used,
he will be excluded from the study. An additional approximately 30-35 ml of
blood will be drawn for analysis of oxygen saturation and biomarkers. This
should not have any consequences for the patient, since the normally
encountered blood loss during CABG surgery is ~500-1000 ml.
hanzeplein 1
groningen 9713 GZ
NL
hanzeplein 1
groningen 9713 GZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35770.042.11 |