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Completed

NCT Number: NCT02707718

Biomarkers for the Early Identification of Sepsis 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.

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Key information

Conditions

Sepsis Disease Disease Attributes Emergencies Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié Salpêtrière, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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

Primary outcomes

  1. sepsis diagnosis

    Time frame: 30-day after inclusion

    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

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

    Time frame: 30-day after inclusion

    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.

Sponsors and collaborators

Lead sponsor

Pitié-Salpêtrière Hospital

Other

Collaborators

  • Bio-Rad Laboratories
  • Institut Pasteur

Registry information

Official study title

Early Biomarkers of Sepsis Identification in the Emergency Department

Acronym: BIPS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2016
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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