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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:
Collaborators:
Hutchinson Technology Inc
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT00167596
First received: September 9, 2005
Last updated: March 19, 2010
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: from randomization to Day 28 ] [ Designated as safety issue: Yes ]
  • length of the hospital stay [ Time Frame: from randomization to Day 90 ] [ Designated as safety issue: Yes ]

Enrollment: 101
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Djillali Annane, University of Versailles SQY, Assistance Publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00167596     History of Changes
Other Study ID Numbers: 05008
Study First Received: September 9, 2005
Last Updated: March 19, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on June 17, 2013