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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Sepsis and Septic Shock
• Intervention / Treatment: Biological: blood sample

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice
    • Contact: Vanina OLIVERI, CRA; Phone Number: 0033 4 92 03 42 54; Email: oliveri.v@chu-nice.fr
    • Principal Investigator: Julie CONTENTI, PH
    • Sub-Investigator: Hervé CORRAZE, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patient with septic shock or severe sepsis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with sepsis; Patients admitted to the emergency department and with criteria of sepsis.	Biological: blood sample; Dosage of presepsine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presepsine and lactate values	Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis shock	Sepsis shock. (Sepsis shock will be defined if blood pressure is < 90mmhg after fluid resuscitation or if catecholamine is used)	Day 0
Mortality	Mortality at J-28	Day 28
Germs responsible of sepsis	Type of germs responsible of sepsis (found on blood culture in emergency department)	Day 0
PIRO Score	P.I.R.O score at the admission in ED	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Julie CONTENTI, PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 21, 2016
• Last Update Submitted That Met QC Criteria: March 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 14-PP-15