Biomarkers for the Early Identification of Sepsis in the Emergency Department (BIPS)

Early Biomarkers of Sepsis Identification in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Biological: blood sampling

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: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitie Salpétrière
  • Paris, France, 75015
    • Institut Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients attending the ED and suspected to have sepsis

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	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.	30-day after inclusion

Collaborators and Investigators

• Sponsor: Pitié-Salpêtrière Hospital
• Collaborators: Institut Pasteur; Bio-Rad Laboratories
• Investigators: Principal Investigator: pierre Hausfater, Md PhD, ARCEAR

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 3, 2018
• Study Completion (Actual): March 3, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: biomarker; sepsis; emergency department; diagnosis; prognostic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: BIPS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO