TRIAGE: TRIage of Sepsis At emerGency dEpartment

NCT02739152 | Completed DMC

• 1 other identifier: TRIAGE
• Study Type: observational
• Target: 602
• Locations: 2 countries
• Sites: 14

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.

Conditions

Sepsis; Severe Sepsis

Keywords

Sepsis; Severe sepsis; Infections; Worsening

Outcome Measures

Primary Outcomes (1)

• patient worsening within a time frame of 72h,change, from day of inclusion, in Sequential Organ Failure Assessment score (SOFA) and/or sepsis classification

  A biostatistics analysis will be led in two steps. The first analysis or "train set" will be conducted on the first 150 patients enrolled, estimated size to reach statistical performance. The objective is to identify markers associated with clinical worsening of patients and decide on a model by selecting the best combination of markers. In a second time, performance will be confirmed during the "test set". The number of samples to be tested depends on the target performance calculated with the area under the Receiver operating characteristic (ROC) curve (AUC). We decided to aim for an AUC of 0.75, based on the performance described in the literature for some triage score as MEDS (Mortality in Emergency Department Sepsis) or those associated with Lactate concentration used as marker of sepsis deterioration in ED

  Up to 72 hours after admission

Secondary Outcomes (1)

• patient status at D28 (alive or death)

  Up to 28 days after admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient freshly admitted to Emergency department

You may qualify if:

• 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

You may not qualify if:

• 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 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 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

Sponsors & Collaborators

• BioMérieux: lead
• Centre Investigation Clinique, Limoges: collaborator

Study Sites (14)

Cliniques universitaires Saint-Luc - UCL

Brussels, 1200, Belgium

Location

Centre hospitalier universitaire Grenoble Alpes

Grenoble, La Tronche, 38700, France

Location

Centre Hospitalier Angoulême

Angoulême, 16959, France

Location

Centre Hospitalier Henri Mondor

Aurillac, 15000, France

Location

Centre Hospitalier Regional Universitaire de Besançon

Besançon, 25030, France

Location

Centre Hospitalier Brive La Gaillarde

Brive-la-Gaillarde, 19100, France

Location

Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon

La Roche-sur-Yon, 85000, France

Location

Centre d'Investigation Clinique (CIC)-CHU Limoges

Limoges, 87042, France

Location

Centre Hospitalier Universitaire Edouard Herriot

Lyon, 69003, France

Location

Centre Hospitalier de Montauban

Montauban, 82013, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

Assistance publique - Hôpitaux de Paris Hopital de Cochin

Paris, 75014, France

Location

Centre Hospitalier Régional Universitaire de Tours

Tours, 37044, France

Location

Centre Hospitalier de Versailles

Versailles, France

Location

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (13); BE (1)