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

NCT02300415 | Unknown

• 1 other identifier: 14-PP-15
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis and Septic Shock

Outcome Measures

Primary Outcomes (1)

• Presepsine and lactate values

  Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria

  Day 0

Secondary Outcomes (4)

• Sepsis shock

  Day 0

• Mortality

  Day 28

• Germs responsible of sepsis

  Day 0

• PIRO Score

  Day 0

Study Arms (1)

patient with sepsis

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

Biological: blood sample

Interventions

blood sample BIOLOGICAL

Dosage of presepsine

patient with sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with septic shock or severe sepsis

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

total blood sample

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julie CONTENTI, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanina OLIVERI, CRA

CONTACT

0033 4 92 03 42 54; oliveri.v@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

FR (1)