Near Infrared Spectroscopy (NIRS) in Severe Sepsis

Phase 3TerminatedNCT00167596

University of Versailles103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Critical Illness Severe Sepsis

Interventions

Near Infrared SpectroscopyDEVICE

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

conventionalDEVICE

resuscitation will be based according to Surviving Sepsis Campaign

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Raymond Poincaré Hospital

Garches, France

Hôpital Nord AP HM

Marseille, France

CHU Tours

Tours, France

GERLACH Herwig

Berlin, Germany

Outcomes

Primary Outcomes

A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint

Time frame: Day 7

Secondary Outcomes

duration of mechanical ventilation

Time frame: from randomization to Day 28

length of the hospital stay

Time frame: from randomization to Day 90

Data from ClinicalTrials.gov

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