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Near Infrared Spectroscopy (NIRS) in Severe Sepsis (OTO-STS)

This study has been terminated.
(recruitment was stopped as consequence of cessation of funding (economic crisis))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167596
First Posted: September 14, 2005
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hutchinson Technology Inc
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles
  Purpose
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.

Condition Intervention Phase
Critical Illness Severe Sepsis Device: Near Infrared Spectroscopy Device: conventional Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Djillali Annane, University of Versailles:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: from randomization to Day 28 ]
  • length of the hospital stay [ Time Frame: from randomization to Day 90 ]

Enrollment: 103
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early goal directed therapy based on StO2 evaluation
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
Active Comparator: 2
Early goal directed therapy
Device: conventional
resuscitation will be based according to Surviving Sepsis Campaign

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167596


Locations
France
Raymond Poincaré Hospital
Garches, France, 92380
Hôpital Nord AP HM
Marseilles, France, 13
CHU Tours
Tours, France
Germany
GERLACH Herwig
Berlin, Germany
University Hospital Rostock
Rostock, Germany, 18057
Greece
NANAS Serafeim
Athens, Greece
Spain
EZAVALA Elizabeth
Barcelona, Spain
Sponsors and Collaborators
University of Versailles
Hutchinson Technology Inc
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Djillali Annane, MD, PhD Raymond Poincaré Hospital, AP-HP
Study Director: Olivier Nardi, MD Raymond Poincaré Hospital, AP-HP
Principal Investigator: Gwenhael Colin, MD Raymond Poincaré Hospital, AP-HP
  More Information

Responsible Party: Djillali Annane, Professor in medicine, University of Versailles
ClinicalTrials.gov Identifier: NCT00167596     History of Changes
Other Study ID Numbers: 05008
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Djillali Annane, University of Versailles:
near infrared spectroscopy
tissue oxygenation
organ dysfunction
mortality

Additional relevant MeSH terms:
Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes