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

University of Versailles

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Critical Illness; Severe Sepsis

Treatments: Device: Near Infrared Spectroscopy; Device: conventional

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00167596

05008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

1

Experimental group

Description:

Early goal directed therapy based on StO2 evaluation

Treatment:

Device: Near Infrared Spectroscopy

2

Active Comparator group

Description:

Early goal directed therapy

Treatment:

Device: conventional