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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560611
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
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.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
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 Intervention
Cardiac Surgical Procedures High-risk Surgical Patient Anaerobic Threshold Device: Near infrared spectroscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Estimated Enrollment: 60
Study Start Date: March 2012
Groups/Cohorts Assigned Interventions
High-risk cardiac surgery patient Device: Near infrared spectroscopy

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01560611


Contacts
Contact: Julien POTTECHER, MD 33.3.88.12.70.95 julien.pottecher@chru-strasbourg.fr

Locations
France
Pôle d'anesthésie réanimation - Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France
Contact: Julien POTTECHER, MD    33.3.88.12.70.95    julien.pottecher@chru-strasbourg.fr   
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
Investigators
Principal Investigator: Julien POTTECHER, MD Strasbourg University Hospital
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01560611     History of Changes
Other Study ID Numbers: 5162
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: March 2012