Clinical trial NCT02738164: SEPSIS 3 Critera for Risk Stratification in Emergency Patients
Official title: Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Emergency
Lead sponsor: Societe Française de Medecine d'urgence
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency patients with infection

Brief summary: Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.

Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection


Eligibility criteria: Inclusion Criteria:

* Adult that present to the emergency department
* Diagnosis of infection by the treating emergency physician

Exclusion Criteria:

* Refuse to participate
* pregnancy
* prisoner
* Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)

Primary outcomes:
measure: In hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: admission in ICU
timeFrame: 30 days
measure: length of ICU stay more than 72 hours
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: St Luc
city: Angers
country: France
facility: CHU Angers
city: Beaumont s Oise
country: France
facility: CHIPO
city: Bobigny
country: France
facility: Avicenne
city: Bry sur Marne
country: France
facility: Saint Camille
city: Dijon
country: France
facility: Dijon
city: Grenoble
country: France
facility: Grenoble
city: Longjumeau
country: France
facility: Longjumeau
city: Lyon
country: France
facility: Lyon
city: Monaco
country: France
facility: Princess Grace
city: Nancy
country: France
facility: Nancy
city: Nice
country: France
facility: Nice
city: Paris
country: France
facility: Ambroise Paré
city: Paris
country: France
facility: Bichat
city: Paris
country: France
facility: Cochin
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Lariboisière
city: Paris
country: France
facility: Pitie-salpetriere
city: Paris
country: France
facility: Saint-Antoine
city: Paris
country: France
facility: St Louis
city: Paris
country: France
facility: Tenon
city: Strasbourg
country: France
facility: Strasbourg
city: Toulouse
country: France
facility: Toulouse
city: Tours
country: France
facility: Tours
city: Vienne
country: France
facility: Vienne
city: Barcelona
country: Spain
facility: Clinic hospital Barcelona
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: SFMU
name: Yonathan Freund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.