Clinical trial NCT02739152: TRIAGE: TRIage of Sepsis At emerGency dEpartment
Official title: TRIAGE: TRIage of Sepsis At emerGency dEpartment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Severe Sepsis
Keywords: Sepsis
Severe sepsis
Infections
Worsening
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
Collaborators: name: Centre Investigation Clinique, Limoges
First posted: 2016-04-15
Enrollment: 602
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: Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.

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. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. 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 TRIAGE project is to identify and 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:

* Male or female aged over 18 years
* Patient with a single acute infection site suspected or confirmed by the clinician on clinical or paraclinical manifestations.
* Patient admitted to ED with at least two systemic inflammatory response syndrome (SIRS) criteria
* Patient with symptoms for less than 72 hours upon arrival to the emergency department.
* Patient requiring according to physician judgment of hospitalization for at least 48 hours for his septic episode
* Patient having been informed of the conditions of the study and having signed the informed consent form

Exclusion Criteria:

* Patient arrived in an emergency room for over 6 hours.
* Patient with septic shock upon arrival to the ED Patient with acute organ failure on arrival at emergencies other than septic.
* Patient hospitalized in the week before inclusion.
* Patient immunocompromised (HIV, transplanted, patients undergoing chemotherapy, patients receiving treatment\> 20 mg / day of prednisolone or equivalent).
* Patient with known pathology among non-infectious pathologies potentially associated with SIRS
* Patient diagnosed with sepsis within 30 days before the date of inclusion.
* Patient has already been included in the study.
* Minor Person.
* Person refusing to sign the written consent form.
* Pregnant woman parturient or nursing.
* Patient with no social security insurance, with restricted liberty or under legal protection

Primary outcomes:
measure: patient worsening within a time frame of 72h,change, from day of inclusion, in Sequential Organ Failure Assessment score (SOFA) and/or sepsis classification
timeFrame: Up to 72 hours after admission
Secondary outcomes:
measure: patient status at D28 (alive or death)
timeFrame: Up to 28 days after admission
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc - UCL
city: Grenoble
country: France
facility: Centre hospitalier universitaire Grenoble Alpes
state: La Tronche
city: Angoulême
country: France
facility: Centre Hospitalier Angoulême
city: Aurillac
country: France
facility: Centre Hospitalier Henri Mondor
city: Besançon
country: France
facility: Centre Hospitalier Regional Universitaire de Besançon
city: Brive La Gaillarde
country: France
facility: Centre Hospitalier Brive La Gaillarde
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon
city: Limoges
country: France
facility: Centre d'Investigation Clinique (CIC)-CHU Limoges
city: Lyon
country: France
facility: Centre Hospitalier Universitaire Edouard Herriot
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Assistance publique - Hôpitaux de Paris Hopital de Cochin
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours
city: Versailles
country: France
facility: Centre Hospitalier de Versailles
Study officials:
References: