Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- University of Versailles
- Enrollment
- 103
- Locations
- 7
- Primary Endpoint
- A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Djillali Annane
Professor in medicine
University of Versailles
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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- duration of mechanical ventilation(from randomization to Day 28)
- length of the hospital stay(from randomization to Day 90)