Near Infrared Spectroscopy (NIRS) in Severe Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Critical Illness Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Early goal directed therapy based on StO2 evaluation

Group Type EXPERIMENTAL

Near Infrared Spectroscopy

Intervention Type DEVICE

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

2

Early goal directed therapy

Group Type ACTIVE_COMPARATOR

conventional

Intervention Type DEVICE

resuscitation will be based according to Surviving Sepsis Campaign

Interventions

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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

Intervention Type DEVICE

conventional

resuscitation will be based according to Surviving Sepsis Campaign

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No