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Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery (Tête-à-coeur)

This study has been completed.
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Alain Deschamps, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01432184
First received: August 26, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Cerebral Hypoxia
Procedure: strategies to reverse decrease in rSO2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Perioperative complications [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    -new, persistent Q-wave myocardial infarction


Secondary Outcome Measures:
  • First 30 days post-operative outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • readmission to hospital within 30 days
    • death

  • ICU data [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
    • ICU admission and discharge times
    • tracheal extubation time in hours

  • First 24 hours complications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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


Enrollment: 200
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.
Procedure: strategies to reverse decrease in rSO2
an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.
Other Name: Cerebral Oxymetry decrease
No Intervention: Control
the cerebral oxymetry screen will be blinded and changes in NIRS values will be unknown to the anesthesiologist. The management of the case will proceed as per normal local practice. The screen will remain blinded in the ICU and the intensivist will not see the values.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432184

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Université de Montréal
Investigators
Principal Investigator: Alain Deschamps, MD, FRCPC Montreal Heart Institute
  More Information

Publications:
Deschamps A, Rochon A, Lebon J-S, Ayoub C, Qizilbash B, Couture P, Cogan J, Toledano K, Bélisle S, Hemmings G, Taillefer J, Blain R, Denault A: Decreases in Cerebal Oxygen Saturation: an algorithmic approach. Canadian Anaesthetists' Society Journal 2009; Abstract: #613224

Responsible Party: Alain Deschamps, PhD, MD, FRCPC,, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01432184     History of Changes
Other Study ID Numbers: ICM 08-1009
Study First Received: August 26, 2011
Last Updated: October 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
cerebral
hypoxia

Additional relevant MeSH terms:
Hypoxia, Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014