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| Sponsors and Collaborators: |
University of Versailles Hutchinson Technology Inc AP-HP |
|---|---|
| Information provided by: | University of Versailles |
| ClinicalTrials.gov Identifier: | NCT00167596 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Critical Illness Severe Sepsis |
Device: Near Infrared Spectroscopy Device: conventional |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis |
| Estimated Enrollment: | 190 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Early goal directed therapy based on StO2 evaluation
|
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
|
|
2: Active Comparator
Early goal directed therapy
|
Device: conventional
resuscitation will be based according to Surviving Sepsis Campaign
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
Exclusion Criteria:
Contacts and Locations| Contact: Djillali Annane, MD, PhD | 331 47 10 77 87 | djillali.annane@rpc.aphp.fr |
| Contact: Olivier Nardy, MD | 331 47 10 77 87 | olivier.nardy@rpc.aphp.fr |
| France | |
| Raymond Poincaré Hospital | Recruiting |
| Garches, France, 92380 | |
| Contact: Olivier Nardi, MD 33147107787 olivier.nardi@rpc.aphp.fr | |
| Contact: Gwenhael Colin, MD 33147107787 gwenhael.colin@rpc.aphp.fr | |
| Sub-Investigator: Tarek Sharshar | |
| Sub-Investigator: David Orlikowski | |
| Sub-Investigator: Bernard Clair | |
| Sub-Investigator: Jérôme Aboab | |
| Sub-Investigator: Georges Loubert | |
| Sub-Investigator: Diane Lipiner | |
| Sub-Investigator: Hélène Gonzalez | |
| Sub-Investigator: Virginie Maxime | |
| Hôpital Nord AP HM | Recruiting |
| Marseilles, France, 13 | |
| Contact: Claude Martin, MD claude.martin@mail.ap-hm.fr | |
| Principal Investigator: Claude Martin, MD | |
| Sub-Investigator: MArc Leone, MD | |
| CHU Tours | Recruiting |
| Tours, France | |
| Contact: Dominique Ferrandières | |
| Principal Investigator: Dominique Ferrandières, MD | |
| Germany | |
| GERLACH Herwig | Recruiting |
| Berlin, Germany | |
| Contact: Herwig GERLACH herwig.gerlach@vivantes.de | |
| Principal Investigator: Herwig GERLACH | |
| University Hospital Rostock | Recruiting |
| Rostock, Germany, 18057 | |
| Contact: Thomas WL Scheeren, MD,PhD | |
| Principal Investigator: Thomas WL Scheeren, MD,PhD | |
| Greece | |
| NANAS Serafeim | Recruiting |
| Athens, Greece | |
| Contact: Serafeim NANAS snanas@cc.uoa.gr | |
| Principal Investigator: Serafeim NANAS | |
| Spain | |
| EZAVALA Elizabeth | Recruiting |
| Barcelona, Spain | |
| Contact: Elizabeth EZVALA EZAVALA@clinic.ub.es | |
| Principal Investigator: Elizabeth EZAVALA | |
| Study Chair: | Djillali Annane, MD, PhD | Raymond Poincaré Hospital, AP-HP |
| Study Director: | Olivier Nardi, MD | Raymond Poincaré Hospital, AP-HP |
| Principal Investigator: | Gwenhael Colin, MD | Raymond Poincaré Hospital, AP-HP |
More Information
| Responsible Party: | University of Versailles SQY, Assistance Publique Hôpitaux de Paris ( Djillali Annane ) |
| Study ID Numbers: | 05008 |
| Study First Received: | September 9, 2005 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00167596 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
near infrared spectroscopy tissue oxygenation organ dysfunction mortality |
|
Systemic Inflammatory Response Syndrome Sepsis Critical Illness Inflammation |
|
Systemic Inflammatory Response Syndrome Disease Attributes Sepsis Pathologic Processes |
Critical Illness Infection Inflammation |
