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

Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness; Severe Sepsis
• Intervention / Treatment: Device: Near Infrared Spectroscopy; Device: conventional

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Raymond Poincaré Hospital
  • Marseilles, France, 13
    • Hôpital Nord AP HM
  • Tours, France
    • Chu Tours
• Germany
  • Berlin, Germany
    • GERLACH Herwig
  • Rostock, Germany, 18057
    • University Hospital Rostock
• Greece
  • Athens, Greece
    • NANAS Serafeim
• Spain
  • Barcelona, Spain
    • EZAVALA Elizabeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
duration of mechanical ventilation	from randomization to Day 28
length of the hospital stay	from randomization to Day 90

Collaborators and Investigators

• Sponsor: University of Versailles
• Collaborators: Assistance Publique - Hôpitaux de Paris; Hutchinson Technology Inc
• Investigators: Study Director: Olivier Nardi, MD, Raymond Poincaré Hospital, AP-HP; Principal Investigator: Gwenhael Colin, MD, Raymond Poincaré Hospital, AP-HP

Publications and helpful links

General Publications

• Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (ESTIMATE): September 14, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: mortality; organ dysfunction; near infrared spectroscopy; tissue oxygenation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Critical Illness
• Other Study ID Numbers: 05008