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recruitment was stopped as consequence of cessation of funding (economic crisis)
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| Name | Class |
|---|---|
| Hutchinson Technology Inc | INDUSTRY |
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Early goal directed therapy based on StO2 evaluation |
|
| 2 | Active Comparator | Early goal directed therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Spectroscopy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of mechanical ventilation | from randomization to Day 28 | |
| length of the hospital stay | from randomization to Day 90 |
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Inclusion Criteria:
Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Djillali Annane, MD, PhD | Raymond Poincaré Hospital, AP-HP | Study Chair |
| Olivier Nardi, MD | Raymond Poincaré Hospital, AP-HP | Study Director |
| Gwenhael Colin, MD | Raymond Poincaré Hospital, AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincaré Hospital | Garches | 92380 | France | |||
| Hôpital Nord AP HM |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29555789 | Derived | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| conventional | Device | resuscitation will be based according to Surviving Sepsis Campaign |
|
| Marseille |
| 13 |
| France |
| CHU Tours | Tours | France |
| GERLACH Herwig | Berlin | Germany |
| University Hospital Rostock | Rostock | 18057 | Germany |
| NANAS Serafeim | Athens | Greece |
| EZAVALA Elizabeth | Barcelona | Spain |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |