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Microcirculation of the Thenar Eminence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01748266
First received: December 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes

December 7, 2012
December 11, 2012
April 2010
August 2011   (final data collection date for primary outcome measure)
microcirculatory reactivity [ Time Frame: 10 minutes before anesthésia induction ] [ Designated as safety issue: No ]
Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence
Same as current
Complete list of historical versions of study NCT01748266 on ClinicalTrials.gov Archive Site
microcirculatory reactivity [ Time Frame: during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB ] [ Designated as safety issue: No ]
Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence
Same as current
Not Provided
Not Provided
 
Microcirculation of the Thenar Eminence
Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass

Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.

40 patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB were included in this prospective observational study. Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Organ dysfunction was assessed with the SOFA score.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB
Elective Cardiac Surgery
Other: microcirculatory reactivity
Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.
microcirculatory reactivity
Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.
Intervention: Other: microcirculatory reactivity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome

Exclusion Criteria:

  • BMI>35
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01748266
1008018, 2010-A00172-37
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Jerome MOREL, Md CHU SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
December 2012

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