Clinical trial NCT01432184: Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery
Official title: Perioperative Interventions to Optimize Cerebral Oxygen Saturation (rSO2) in High-risk Patients Undergoing Cardiac Surgery Should Have a Beneficial Systemic Effect for Enhancing Global Tissue Perfusion and Improve Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Hypoxia
Keywords: cerebral
hypoxia
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2011-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using the brain and the heart as index organs, perioperative interventions to optimize cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac surgery should have a beneficial systemic effect for enhancing global tissue perfusion and improve outcomes.

Detailed description: The proportion of high-risk patients requiring cardiac surgery and of high-risk cardiac surgeries is increasing. These populations of patients are at increased risk of perioperative morbidity and mortality. Transesophageal echocardiography (TEE) evaluation in cardiac surgery has been shown to impact on the perioperative management of patients and to improve outcomes. Near infrared-reflectance spectroscopy (NIRS) is a technique that has been employed since the mid-1970's and that can be used as a non-invasive and continuous monitor of the balance between cerebral oxygen delivery and consumption. Two recent randomized trials have shown an association between correction of cerebral desaturation and shorter recovery room and hospital stay in non-cardiac surgery, and with a decrease in major organ dysfunction and in intensive care length of stay after coronary artery bypass. By combining NIRS and TEE in high-risk patients, optimal tissue perfusion could be achieved and perioperative morbidity and mortality could be reduced.

Eligibility criteria: Inclusion Criteria:

* Patients with EUROSCORES ≥ 10.
* Planned complex surgery including more than one procedure, or redo procedures.
* Patient able to read and understand the consent form.
* Patients ≥ 18 years of age.

Exclusion Criteria:

* High risk patients undergoing of off pump coronary artery bypass.
* Emergency surgeries less than 6 hours from diagnosis.
* Patient unable to read and understand the consent form.
* Patients with and IABP or a ventricular assist device
* Planned circulatory arrest
* Planned surgery of the descending aorta.
* Patients with acute endocarditis.

Primary outcomes:
measure: Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group.
timeFrame: Up to 12 hours
Secondary outcomes:
measure: First 30 days post-operative outcomes
timeFrame: 30 days
measure: ICU data
timeFrame: Up to 48 hours
measure: First 24 hours complications
timeFrame: 24 hours
measure: Post-operative complications
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Alain Deschamps, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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