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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
  Purpose

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.


Condition Intervention
Elective Cardiac Surgery
Other: microcirculatory reactivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: microcirculatory reactivity
Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748266

Locations
France
Chu Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Jerome MOREL, Md CHU SAINT-ETIENNE
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01748266     History of Changes
Other Study ID Numbers: 1008018, 2010-A00172-37
Study First Received: December 7, 2012
Last Updated: December 11, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
StO2
microcirculation
NIRS

ClinicalTrials.gov processed this record on November 27, 2014