Critical Illness Clinical Trial
Official title:
Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.
The systemic inflammatory response to sepsis may cause impaired tissue oxygenation that can
persist despite the restoration of a normal hemodynamic profile and systemic oxygen
transport.
Therefore, the assessment of tissue oxygenation and perfusion is recommended in patients
with severe sepsis.
The InSpectra tissue spectrometer relies on continuous wave near infrared (NIR) technology
to estimate non invasively local tissue hemoglobin oxygen saturation in tissue (% StO2).
This technology had been tested in a variety of systems: standard theoretical models of
light transport, isolated blood, isolated blood-perfused animal organs and healthy human
volunteers with induced limb ischemia. In critical-care medicine, NIRS has also been used to
evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal
compartment syndrome. However, NIRS has been rarely utilised to measure tissue blood flow
and oxygen uptake in critically ill patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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