Clinical trial NCT04261621: Early Identification of SEPsis SIGNs in Emergency Department
Official title: Early Identification of SEPsis SIGNs in Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Sepsis
Keywords: Infection
Sepsis
Worsening
Emergency Department
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
name: Centre d'Investigation Clinique - Limoges
First posted: 2020-02-10
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient freshly admitted to Emergency department

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: number of patients with deterioration within 72-hour period following T0 (enrollment)
timeFrame: Up to 72 hours after admission
Secondary outcomes:
measure: Number of Participants that have been re-admission
timeFrame: Up to 28 days after admission
measure: Number of patients with Early and late mortality
timeFrame: Up to 28 days after admission
measure: number of patients with confirmed bacterial and viral infection
timeFrame: Up to 28 days after admission
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Aurillac
country: France
facility: CH Henri Mondor Aurillac
city: La Tronche
country: France
facility: CHU Grenoble alpes
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot, HCL
city: Montauban
country: France
facility: CH de Montauban
city: Paris
country: France
facility: Hôpital Saint-Antoine AP-HP
city: Tours
country: France
facility: Hôpital Trousseau CHRU
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References: