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Tissue Oxygenation During Heart Surgery

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ClinicalTrials.gov Identifier: NCT01347827
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Center Groningen

Brief Summary:
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, the investigators 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, the investigators aim to determine if duration and extent of cerebral oxygen desaturation predict outcome variables such as postoperative cognitive performance.

Condition or disease Intervention/treatment
Coronary Artery Bypass Grafting Device: measurements of brain tissue oxygenation

Study Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Comparison of Cerebral Tissue Oxygen Desaturation in Patients Undergoing On-pump or Off-pump Coronary Artery Bypass Grafting
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
on pump
Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass
Device: measurements of brain tissue oxygenation
different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter)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

off pump
off-pump CABG surgery
Device: measurements of brain tissue oxygenation
different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter) 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




Primary Outcome Measures :
  1. incidence of significant brain tissue oxygen desaturation, defined as AUC40 > 600 %.sec (a function of both duration (in seconds) and severity (saturation < 40%) of desaturation). [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Oxygenation measurements: Peripheral muscle StO2, cerebral and renal StO2, ScvO2, SaO2, arteriovenous oxygen difference, pO2 Acid-base status: pH, pCO2, HCO3-, ABE, lactate [ Time Frame: 3 months ]
    • To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with each other
    • To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with conventional hemodynamic and metabolic variables such as central venous oxygen saturation (ScvO2).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 consecutive adult patients scheduled for elective CABG surgery will be randomized to have the surgery performed either on-pump (n=30) or off-pump CABG (n=30).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347827


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Thomas W.L. Scheeren, Prof.dr University Medical Center Groningen

Responsible Party: MMRF Struys, Prof.dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01347827     History of Changes
Other Study ID Numbers: TO-CABG
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by MMRF Struys, University Medical Center Groningen:
Coronary artery bypass surgery
Oximetry
Brain metabolism