Near Infrared Spectroscopy (NIRS) in Severe Sepsis

Critical Illness Clinical Trial

— OTO-STS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00167596
• Other study ID #: 05008
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: July 19, 2016
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: July 2016
• Source: University of Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Severe Sepsis
• Toxemia

Intervention

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
• conventional
resuscitation will be based according to Surviving Sepsis Campaign

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	Garches
France	Hôpital Nord AP HM	Marseilles
France	CHU Tours	Tours
Germany	GERLACH Herwig	Berlin
Germany	University Hospital Rostock	Rostock
Greece	NANAS Serafeim	Athens
Spain	EZAVALA Elizabeth	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
University of Versailles	Assistance Publique - Hôpitaux de Paris, Hutchinson Technology Inc

Countries where clinical trial is conducted

France,  Germany,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint		Day 7	Yes
Secondary	duration of mechanical ventilation		from randomization to Day 28	Yes
Secondary	length of the hospital stay		from randomization to Day 90	Yes