Severe Sepsis and Septic Shock
Conditions
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.
Interventions
BIOLOGICALblood sample
Dosage of presepsine
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presepsine and lactate values | Day 0 | Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis shock | Day 0 | Sepsis shock. (Sepsis shock will be defined if blood pressure is \< 90mmhg after fluid resuscitation or if catecholamine is used) |
| Mortality | Day 28 | Mortality at J-28 |
| Germs responsible of sepsis | Day 0 | Type of germs responsible of sepsis (found on blood culture in emergency department) |
| PIRO Score | Day 0 | P.I.R.O score at the admission in ED |
Contacts
PRINCIPAL_INVESTIGATORJulie CONTENTI, PH
Centre Hospitalier Universitaire de Nice
Outcome results
None listed