NCT00167596

Near Infrared Spectroscopy (NIRS) in Severe Sepsis

Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: University of Versailles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Critical Illness
• Severe Sepsis

Interventions

Type	Name	Description
DEVICE	Near Infrared Spectroscopy	resuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid
DEVICE	conventional	resuscitation will be based according to Surviving Sepsis Campaign

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-05-01
• Completion: 2009-12-01
• First posted: 2005-09-14
• Last updated: 2016-07-20

Locations

7 sites across 4 countries: France, Germany, Greece, Spain