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

Severe Sepsis and Septic Shock Clinical Trial

— PREDI  

Official title:

Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02300415
• Other study ID #: 14-PP-15
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2014
• Last updated: July 7, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Vanina OLIVERI, CRA
• Phone: 0033 4 92 03 42 54
• Email: oliveri.v[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis and Septic Shock
• Toxemia

Intervention

Biological:
• blood sample
Dosage of presepsine

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presepsine and lactate values	Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria	Day 0	No
Secondary	Sepsis shock	Sepsis shock. (Sepsis shock will be defined if blood pressure is < 90mmhg after fluid resuscitation or if catecholamine is used)	Day 0	No
Secondary	Mortality	Mortality at J-28	Day 28	No
Secondary	Germs responsible of sepsis	Type of germs responsible of sepsis (found on blood culture in emergency department)	Day 0	No
Secondary	PIRO Score	P.I.R.O score at the admission in ED	Day 0	No