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Completed

NCT Number: NCT01748266

Microcirculation of the Thenar Eminence

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.

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Key information

Conditions

Elective Cardiac Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microcirculatory reactivity

Other

Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.

Primary outcomes

  1. microcirculatory reactivity

    Time frame: 10 minutes before anesthésia induction

    Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence

Secondary outcomes

  1. 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

    Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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