A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01560611
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: March 2012

March 20, 2012
March 21, 2012
March 2012
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Complete list of historical versions of study NCT01560611 on ClinicalTrials.gov Archive Site
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A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery
The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient

In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients undergoing cardiac surgical procedures under cardiopulmonary bypass in Strasbourg University Hospital

  • Cardiac Surgical Procedures
  • High-risk Surgical Patient
  • Anaerobic Threshold
Device: Near infrared spectroscopy
High-risk cardiac surgery patient
Intervention: Device: Near infrared spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
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Inclusion Criteria:

  • Age > 18 yo
  • Cardiac surgical procedure under cardiopulmonary bypass
  • High-risk surgical patient fulfilling one of the following items:

    • Euroscore >= 6
    • Ejection fraction < 40%
    • Creatinine clearance < 40mL/min
    • Pulmonary arterial pressure > 45mmHg
  • Signed informed consent
  • Social security affiliation

Exclusion Criteria:

  • Emergency situation
  • Patient on ECMO
  • Pregnancy or lactation
Both
18 Years and older
No
Contact: Julien POTTECHER, MD 33.3.88.12.70.95 julien.pottecher@chru-strasbourg.fr
France
 
NCT01560611
5162
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Julien POTTECHER, MD Strasbourg University Hospital
University Hospital, Strasbourg, France
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP