Biomarkers for the Early Identification of Sepsis in the Emergency Department

Sepsis Clinical Trial

— BIPS  

Official title:

Early Biomarkers of Sepsis Identification in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707718
• Other study ID #: BIPS study
• Status: Completed
• First received: February 26, 2016
• Last updated: April 13, 2018
• Start date: March 1, 2016
• Est. completion date: March 3, 2018

Study information

• Verified date: April 2018
• Source: Pitié-Salpêtrière Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 3, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Hôpital Pitié Salpêtrière	Paris
France	Institut Pasteur	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Pitié-Salpêtrière Hospital	Bio-Rad Laboratories, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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