Clinical trial NCT00167596: Near Infrared Spectroscopy (NIRS) in Severe Sepsis
Official title: Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Critical Illness
Severe Sepsis
Keywords: near infrared spectroscopy
tissue oxygenation
organ dysfunction
mortality
Lead sponsor: University of Versailles
Sponsor class: OTHER
Collaborators: name: Hutchinson Technology Inc
name: Assistance Publique - Hôpitaux de Paris
First posted: 2005-09-14
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
timeFrame: Day 7
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: from randomization to Day 28
measure: length of the hospital stay
timeFrame: from randomization to Day 90
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
city: Marseilles
country: France
facility: Hôpital Nord AP HM
city: Tours
country: France
facility: CHU Tours
city: Berlin
country: Germany
facility: GERLACH Herwig
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Athens
country: Greece
facility: NANAS Serafeim
city: Barcelona
country: Spain
facility: EZAVALA Elizabeth
Study officials:
affiliation: Raymond Poincaré Hospital, AP-HP
name: Djillali Annane, MD, PhD
role: STUDY_CHAIR
affiliation: Raymond Poincaré Hospital, AP-HP
name: Olivier Nardi, MD
role: STUDY_DIRECTOR
affiliation: Raymond Poincaré Hospital, AP-HP
name: Gwenhael Colin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.