Severe Sepsis and Septic Shock Clinical Trial
Official title:
Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.
Severe sepsis and sepsis shock are common in emergency department, with a high mortality
rate. The potential severity of this disease impose a diagnosis as early as possible to
start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important
support for the emergency physician. However, comparison of sensitivity and specificity for
new biomarkers, like presepsine, suggests that they can be more efficient in this area.
In this single-center, prospective, non-interventional study, we propose to compare the
sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic
shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of
lactate for the diagnosis of severe sepsis.
Severe sepsis and sepsis shock are common in emergency department, with a high mortality
rate. The potential severity of this disease impose a diagnosis as early as possible to
start antibiotic therapy and hemodynamic support. The conventional biomarkers are an
important support for the emergency physician. However, comparison of sensitivity and
specificity for new biomarkers, like presepsine, suggest that they can be more efficient in
this indication. Presepsine is a soluble fragment of CD14, its concentration is a reflection
of cellular activity (macrophages and monocytes) in response of a sepsis's aggression.
Today, it's possible to asses the presepsine value at bedside, with new device (PATHFAST),
in just 17 minutes, reinforcing the interest for this biomarker.
We will conduct a single-center, prospective, non-interventional study, between december
2014 and July 2015 in the university emergency department of Nice. The primary outcome is to
compare the sensitivity of presepsine to lactate for the diagnosis of severe sepsis and
septic shock. The dosage of presepsine will be made in 194 patients over 18 years old , with
at least two S.I.R.S criteria, a suspected infection, and the presence of one organ failure.
The secondary outcomes are to asses the link between the presepsine value and the germ
responsible of sepsis, the correlation between presepsine value at the admission and the
mortality at J-28. And we will try to determine if there is a correlation between the
initial presepsine value, and the P.I.R.O score.
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Observational Model: Case-Only, Time Perspective: Prospective
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