Biomarkers for the Early Identification of Sepsis in the Emergency Department

NCT ID: NCT02707718

Last Updated: 2018-04-17

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

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-03-03

Brief Summary

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Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

Detailed Description

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The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis.

Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection.

Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood sampling

during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam

Exclusion Criteria

* patient minor under 18-year
* pregnancy
* anticipated no follow-up possible (homeless...)
* Refusal to participate
* patient under curators, prisoner
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role collaborator

Bio-Rad Laboratories

INDUSTRY

Sponsor Role collaborator

Pitié-Salpêtrière Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hausfater Pierre

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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pierre Hausfater, Md PhD

Role: PRINCIPAL_INVESTIGATOR

ARCEAR

Locations

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Hôpital Pitié Salpêtrière

Paris, , France

Site Status

Institut Pasteur

Paris, , France

Site Status

Countries

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France

Other Identifiers

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BIPS study

Identifier Type: -

Identifier Source: org_study_id

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