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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Lactate Level for Pre-hospital Orientation of Septic Shock

NCT03831685

Sepsis Lactate Blood Increase

UNKNOWN

Use of Presepsin in the Emergency Department

NCT06150092

Sepsis

RECRUITING

Lactate Use as Triage Tool in Sepsis : Veinous, Capillary or Arterial?

NCT01964690

Sepsis

COMPLETED

Sepsis Early EvaluatioN Through Rapid Ultrasound and veNous Gas Analysis

NCT05787184

Sepsis Septic Shock Shock

UNKNOWN

Predict Sepsis; the Predictive Value of Bedside Measures in the Ambulance

NCT03249597

Sepsis Sepsis Syndrome Sepsis, Severe

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Sepsis and Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient with sepsis

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

blood sample

Intervention Type BIOLOGICAL

Dosage of presepsine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample

Dosage of presepsine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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