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

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ClinicalTrials.gov Identifier: NCT02300415
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : November 25, 2014
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment
Severe Sepsis and Septic Shock 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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

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




Primary Outcome Measures :
  1. Presepsine and lactate values [ Time Frame: Day 0 ]
    Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria


Secondary Outcome Measures :
  1. Sepsis shock [ Time Frame: Day 0 ]
    Sepsis shock. (Sepsis shock will be defined if blood pressure is < 90mmhg after fluid resuscitation or if catecholamine is used)

  2. Mortality [ Time Frame: Day 28 ]
    Mortality at J-28

  3. Germs responsible of sepsis [ Time Frame: Day 0 ]
    Type of germs responsible of sepsis (found on blood culture in emergency department)

  4. PIRO Score [ Time Frame: Day 0 ]
    P.I.R.O score at the admission in ED


Biospecimen Retention:   Samples Without DNA
total blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with septic shock or severe sepsis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300415


Contacts
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Contact: Vanina OLIVERI, CRA 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Vanina OLIVERI, CRA    0033 4 92 03 42 54    oliveri.v@chu-nice.fr   
Principal Investigator: Julie CONTENTI, PH         
Sub-Investigator: Hervé CORRAZE, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Julie CONTENTI, PH Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02300415     History of Changes
Other Study ID Numbers: 14-PP-15
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock