NCT02707718

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 26, 2016

Last Update Submit

April 13, 2018

Conditions

Sepsis

Keywords

sepsisbiomarkerprognosticemergency departmentdiagnosis

Outcome Measures

Primary Outcomes (1)

  • sepsis diagnosis

    Among the patients included in the study with a sepsis suspicion, the primary outcome measure will be a final diagnosis of sepsis adjudicated on the medical file and 30-day follow-up, by an expert panel blind for the biomarkers studied

    30-day after inclusion

Secondary Outcomes (1)

  • severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up

    30-day after inclusion

Interventions

blood samplingBIOLOGICAL

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients attending the ED and suspected to have sepsis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Institut Pasteur

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and sera

MeSH Terms

Conditions

SepsisEmergenciesDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • pierre Hausfater, Md PhD

    ARCEAR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 14, 2016

Study Start

March 1, 2016

Primary Completion

March 3, 2018

Study Completion

March 3, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)