Clinical Trial: Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Perfusio

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 Summary: 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.
Sponsor: Montreal Heart Institute

Current Primary Outcome: Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group. [ Time Frame: Up to 12 hours ]

Consensus on the appropriate strategies to prevent and reverse cerebral oxygen desaturations remains controversial. In a recent study by Slater and al.12, randomization into an intervention group failed because anesthesiologists were unable to follow the protocol aimed at strategies to reverse decreases in rSO2. A group from the Montreal Heart Institute has developed a physiologically oriented algorithm to help with the task of reversing decreases in rSO2. The goal of the present study is therefore to confirm that this approach can be used with success by most institutions.


Original Primary Outcome: Perioperative complications [ Time Frame: Up to 24 hours ]

-new, persistent Q-wave myocardial infarction


Current Secondary Outcome:

  • First 30 days post-operative outcomes [ Time Frame: 30 days ]
    • readmission to hospital within 30 days
    • death
  • ICU data [ Time Frame: Up to 48 hours ]
    • ICU admission and discharge times
    • tracheal extubation time in hours
  • First 24 hours complications [ Time Frame: 24 hours ]
    • clinical stroke manifested as focal neurological deficit persisting 24hr and confirmed by brain computed tomography imaging
    • prolonged ventilation defined as extubation at > 24 h postoperatively
    • new, persistent Q-wave myocardial infarction
  • Post-operative complications [ Time Frame: Up to 7 days ]
    • renal failure as defined by the RIFLE criteria
    • reoperation for any cause
    • arrhythmia requiring treatment
    • Hospital length of stay
    • wound infection requiring specific antibiotic coverage


Original Secondary Outcome:

  • First 30 days post-operative outcomes [ Time Frame: 30 days ]
    • readmission to hospital within 30 days
    • death
  • ICU data [ Time Frame: Up to 48 hours ]
    • ICU admission and discharge times
    • tracheal extubation time in hours
  • First 24 hours complications [ Time Frame: 24 hours ]
    • clinical stroke manifested as focal neurological deficit persisting 24hr and confirmed by brain computed tomography imaging
    • prolonged ventilation defined as extubation at > 24 h postoperatively
  • Post-operative complications [ Time Frame: Up to 7 days ]
    • renal failure as defined by the RIFLE criteria
    • reoperation for any cause
    • arrhythmia requiring treatment
    • Hospital length of stay
    • wound infection requiring specific antibiotic coverage


Information By: Montreal Heart Institute

Dates:
Date Received: August 26, 2011
Date Started: July 2010
Date Completion:
Last Updated: October 16, 2015
Last Verified: October 2015