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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560611
Recruitment Status : Unknown
Verified March 2012 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Surgical Procedures High-risk Surgical Patient Anaerobic Threshold Device: Near infrared spectroscopy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient
Study Start Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Group/Cohort Intervention/treatment
High-risk cardiac surgery patient Device: Near infrared spectroscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cardiac surgical procedures under cardiopulmonary bypass in Strasbourg University Hospital

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

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 identifier (NCT number): NCT01560611

Contact: Julien POTTECHER, MD

Pôle d'anesthésie réanimation - Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France
Contact: Julien POTTECHER, MD   
Sub-Investigator: Olivier COLLANGE, MD         
Sub-Investigator: Pierre DIEMUNSCH, MD         
Sub-Investigator: Hubert GROS, MD         
Sub-Investigator: François LEVY, MD         
Sub-Investigator: Annick STEIB, MD         
Sub-Investigator: Michel KINDO, MD         
Sub-Investigator: Jean-Philippe MAZZUCOTELLI, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Julien POTTECHER, MD Strasbourg University Hospital

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT01560611     History of Changes
Other Study ID Numbers: 5162
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012