- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347827
Tissue Oxygenation During Heart Surgery
January 9, 2013 updated by: MMRF Struys, University Medical Center Groningen
Comparison of Cerebral Tissue Oxygen Desaturation in Patients Undergoing On-pump or Off-pump Coronary Artery Bypass Grafting
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands
- University Medical Center Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
on pump
Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass
|
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
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
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas W.L. Scheeren, Prof.dr, University Medical Center Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 27, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 10, 2013
Last Update Submitted That Met QC Criteria
January 9, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- TO-CABG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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