- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707718
Biomarkers for the Early Identification of Sepsis in the Emergency Department (BIPS)
Early Biomarkers of Sepsis Identification in the Emergency Department
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75013
- Hopital Pitié Salpetrière
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Paris, France, 75015
- Institut Pasteur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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sepsis diagnosis
Time Frame: 30-day after inclusion
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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
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30-day after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up
Time Frame: 30-day after inclusion
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Among the patients included in the study with a sepsis suspicion, a diagnosis of severe sepsis and/or septic shock will be adjudicated on the medical file and 30-day follow-up by an expert panel blind for the biomarkers studied.
ICu admission and death will be recorded by the medical file and 30-day phone interview.
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30-day after inclusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: pierre Hausfater, Md PhD, ARCEAR
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIPS study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
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Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
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