Clinical trial NCT02300415: Comparison of Sensitivity Between Presepsine and Lactate for the Diagnosis of Severe Sepsis.
Official title: Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis and Septic Shock
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with septic shock or severe sepsis

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Presence of at least two SIRS criteria (T °\> 38.3 ° or \<36 °, tachycardia\> 90 / min, tachypnea\> 20 / min, recent alteration of consciousness)
* Suspected Infection
* Indication of an arterial lactate assay on medical advice
* Affiliation to social security
* Informed Consent

Exclusion Criteria:

* Renal dialysis
* Scalable neoplasia chemotherapy
* Patient Palliative Care
* Private Patient freedom or under legal protection

Primary outcomes:
measure: Presepsine and lactate values
timeFrame: Day 0
Secondary outcomes:
measure: Sepsis shock
timeFrame: Day 0
measure: Mortality
timeFrame: Day 28
measure: Germs responsible of sepsis
timeFrame: Day 0
measure: PIRO Score
timeFrame: Day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Julie CONTENTI, PH
role: PRINCIPAL_INVESTIGATOR
References: