Near Infrared Spectroscopy (NIRS) in Severe Sepsis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Severe Sepsis

Intervention / Treatment
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* Device: Near Infrared Spectroscopy
* Device: conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two of four criteria for the systemic inflammatory response syndrome; and one of the following: systolic blood pressure =< 90 mm Hg; or a blood lactate concentration => 4 mmol/l; or skin marbling; or impaired consciousness; or urine output < 30 ml/h. Exclusion Criteria: Age < 18 years Pregnancy Do-not-resuscitate status Advanced directives restricting implementation of the protocol Obesity (body mass index [BMI] > 30) Anasarca

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Early goal directed therapy based on StO2 evaluation | Device: Near Infrared Spectroscopy<br>* 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<br>|
| Active Comparator: 2<br>Early goal directed therapy | Device: conventional<br>* resuscitation will be based according to Surviving Sepsis Campaign<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation |  | from randomization to Day 28 | 
| length of the hospital stay |  | from randomization to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near infrared spectroscopy, tissue oxygenation, organ dysfunction, mortality