Biomarkers for the Early Identification of Sepsis in the Emergency Department (BIPS)
Early Biomarkers of Sepsis Identification in the Emergency Department
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Paris, Frankrike, 75013
- Hôpital Pitie Salpétrière
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Paris, Frankrike, 75015
- Institut Pasteur
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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sepsis diagnosis
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: pierre Hausfater, Md PhD, ARCEAR
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BIPS study
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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