The project was funded by Hutchinson Technologies Company and lasted 12 months (2008 - 2009).
An assessment of tissue perfusion and oxygenation is recommended in patients with sepsis. However, there is no reliable assessment tool available that can be used for patients with these parameters of tissue metabolism.
The main aim of this project was to assess the efficacy of an additional therapeutic strategy, by using non-invasive Near-Infrared Spectroscopy for tissue perfusion and oxygenation (StO2) in patients undergoing treatment for severe sepsis.
The study was held in the Adult Reanimation Unit of Raymond Poincare University Hospital in France, and in other European areas. The study was multicenter, offered prospects and was randomized in parallel groups.
Regarding procedure, patients in the control group were treated according to the international recommendations for hemodynamic optimization. Patients in the experimental group, were treated according to the international recommendations for hemodynamic optimization and for optimization of tissue oxygenation (target StO >80%), for a period of 6 hours.
Patients eligible for participation were of both sexes, aged eighteen and above, who were hospitalized in the Reanimation Unit, and had at least 2 out of the 4 criteria of Inflammatory Response Syndrome, i.e systolic arterial pressure of at least 90 mmHg or a lactate concentration above or equal to 4 mmol/l, or oliguria (< 30 ml/h) or mental confusion, or had skin with a variety of colors or mottled.
The main criteria for the decision, was death or increase by at least 1 point in SOFA score, after 7 days.
Considering that a 20% difference in the main criterion would be clinically significant and that the main criterion was met in 50% of the cases in the control group, 95 subjects were necessary in each group using a bilateral test with a 5% threshold for a power of 80%.
The Intensive Care Unit of Raymond Poincare University Hospital in Paris was the network leader and the Intensive Care Unit of Nicosia General Hospital participated -among others- as a collaborating institution.