Early Identification of SEPsis SIGNs in Emergency Department

Completed

Conditions studied: Infection, Sepsis

In brief

Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.

Key facts

Study ID

NCT04261621

Run by

BioMérieux

People needed

815

Starts

2020-07-06

Expected to finish

2022-05-02

Last updated by the study team

2023-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All of the following criteria:
• Delay between ED presentation and inclusion must not exceed 12h
• Age 18 years or greater
• Acute infection suspected or confirmed
• That fulfills at least two of the following systemic inflammatory response syndrome (SIRS) criteria:
• Temperature > 38°C (100.4°F) or < 36°C (96.8°F)
• Heart rate > 90 bpm
• Respiratory rate > 20 cycles/min or PaCO2 < 32 mmHg
• Leukocyte > 12000/mm3 or < 4000/mm3 or 10% bands
• With a delta SOFA < 2 from baseline
• At Risk for deterioration defined as:
• any patient that the emergency department physician has admitted or intends to admit as an inpatient* to the hospital.
• patients discharged home (outpatient**) who are either i) >65 years old or ii) diagnosed with pneumonia

You may not qualify if…

• Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this include in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1122-8 of the French Public Health Code.)
• Known pregnancy, in labor or breastfeeding
• Patients with isolated uncomplicated pharyngitis, sinusitis, or otitis media
• Infectious symptoms present for > 5 days prior to presentation

Where it is running

• University of Colorado School of Medicine — Aurora, Colorado, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States
• CH Henri Mondor Aurillac — Aurillac, France
• CHU Grenoble alpes — La Tronche, France
• CHU Dupuytren — Limoges, France
• Hopital Edouard Herriot, HCL — Lyon, France
• CH de Montauban — Montauban, France
• Hôpital Saint-Antoine AP-HP — Paris, France
• Hôpital Trousseau CHRU — Tours, France
• Centre Hospitalier Princesse Grace — Monaco, Monaco

Full record on ClinicalTrials.gov

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