Status:
TERMINATED
Near Infrared Spectroscopy (NIRS) in Severe Sepsis
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Hutchinson Technology Inc
Assistance Publique - Hôpitaux de Paris
Conditions:
Critical Illness
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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, t...
Eligibility Criteria
Inclusion
- 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
- Age \< 18 years
- Pregnancy
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Obesity (body mass index \[BMI\] \> 30)
- Anasarca
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00167596
Start Date
July 1 2005
End Date
December 1 2009
Last Update
July 20 2016
Active Locations (7)
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1
Raymond Poincaré Hospital
Garches, France, 92380
2
Hôpital Nord AP HM
Marseille, France, 13
3
CHU Tours
Tours, France
4
GERLACH Herwig
Berlin, Germany