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Tissue Oxygenation During Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01347827
First received: April 27, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Coronary Artery Bypass Grafting
 Device: measurements of brain tissue oxygenation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Cerebral Tissue Oxygen Desaturation in Patients Undergoing On-pump or Off-pump Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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).


Enrollment: 60
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347827

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

No publications provided

Responsible Party: MMRF Struys, Prof.dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01347827     History of Changes
Other Study ID Numbers: TO-CABG
Study First Received: April 27, 2011
Last Updated: January 9, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Coronary artery bypass surgery
Oximetry
Brain metabolism

ClinicalTrials.gov processed this record on May 16, 2013