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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00167596
Acronym
OTO-STS
Enrollment
103
Registered
2005-09-14
Start date
2005-07-31
Completion date
2009-12-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Severe Sepsis

Keywords

near infrared spectroscopy, tissue oxygenation, organ dysfunction, mortality

Brief 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.

Interventions

DEVICENear 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

DEVICEconventional

resuscitation will be based according to Surviving Sepsis Campaign

Sponsors

Hutchinson Technology Inc
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
University of Versailles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
duration of mechanical ventilationfrom randomization to Day 28
length of the hospital stayfrom randomization to Day 90

Countries

France, Germany, Greece, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026