Early Identification of SEPsis SIGNs in Emergency Department (SepSIGN)

bioMérieux

Status: Completed

Conditions: Infection; Sepsis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04261621

SepSIGN

Details and patient eligibility

About

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.

Full description

Sepsis is an important health issue with considerable socio-economic consequences. In 2017, the World Health Association made sepsis a global health priority, and has adopted a resolution to improve the prevention, diagnosis, and management of sepsis.

Over the last decade, a decrease in the mortality rate has been observed; in particular thanks to improved management, more appropriate intervention approaches in the Emergency Department (ED) and better recognition of organ failure. This statement is based on qSOFA and SOFA scores from the international Sepsis-3 definition. Sepsis-3 can help front-line clinicians detect severe patients with a higher risk of mortality but does not predict the clinical deterioration especially in patients without initial organ dysfunction. Furthermore, studies still demonstrate that 20% of patients with infection or uncomplicated sepsis experience disease worsening within 72 hours after ED admission.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities.

Unfortunately, as of today, no biological marker has yet been validated to appropriately predict early deterioration in unselected patients admitted to the ED with acute infection, irrespective of their clinical presentation. Physiology of sepsis is complex and some underlying dysfunction could already exist in the early phase of sepsis before patients meet diagnostic criteria. Thus, patients may be clinically asymptomatic at the origin of organ failure. As a result, doubtful patients are often over-hospitalized while they could be treated at home, leading to overcrowding and extra costs for hospitals In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment. 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, whom blood samples will serve to validate candidate markers.

Enrollment: 815 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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:

  1. any patient that the emergency department physician has admitted or intends to admit as an inpatient* to the hospital.
  2. patients discharged home (outpatient**) who are either i) >65 years old or ii) diagnosed with pneumonia

Exclusion criteria

• 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