Comparison of Sensitivity Between Presepsine and Lactate for the Diagnosis of Severe Sepsis. (PREDI)

Centre Hospitalier Universitaire de Nice

Status: Unknown

Conditions: Severe Sepsis and Septic Shock

Treatments: Biological: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02300415

14-PP-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

patient with sepsis

Description:

Patients admitted to the emergency department and with criteria of sepsis.

Treatment:

Biological: blood sample