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CompletedNCT01347827Updated Apr 18, 2024

Tissue Oxygenation During Heart Surgery

An observational study in Coronary Artery Bypass Grafting, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Coronary Artery Bypass Grafting

Keywords

  • Coronary artery bypass surgery
  • Oximetry
  • Brain metabolism
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In context

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

Inclusion criteria

  • Age ≥18 years
  • Informed patient consent
  • Coronary artery disease suitable for both on-pump and off-pump CABG surgery.

Exclusion criteria

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)

Groups and cohorts

  • on pump

    Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass

    Device: measurements of brain tissue oxygenation

  • off pump

    off-pump CABG surgery

    Device: measurements of brain tissue oxygenation

Interventions

  • Devicemeasurements 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

  • Devicemeasurements 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

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Oxygenation measurements: Peripheral muscle StO2, cerebral and renal StO2, ScvO2, SaO2, arteriovenous oxygen difference, pO2 Acid-base status: pH, pCO2, HCO3-, ABE, lactate

    * 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).

    Time frame: 3 months

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, Netherlands
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References and documents

Publications

  • de Keijzer IN, Poterman M, Absalom AR, Vos JJ, Mariani MA, Scheeren TWL. Comparison of renal region, cerebral and peripheral oxygenation for predicting postoperative renal impairment after CABG. J Clin Monit Comput. 2022 Jun;36(3):735-743. doi: 10.1007/s10877-021-00701-4. Epub 2021 Apr 20. Erratum In: J Clin Monit Comput. 2022 Aug;36(4):1233. doi: 10.1007/s10877-021-00791-0. PubMed 33876337 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01347827
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
May 4, 2011
Start date
Jun 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 18, 2024

Study contacts

Thomas W.L. Scheeren, Prof.dr
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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