TRIAGE: TRIage of Sepsis At emerGency dEpartment

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc - UCL, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Up to 72 hours after admission

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

Secondary outcomes

patient status at D28 (alive or death)

Time frame: Up to 28 days after admission

A biostatistics analysis will be led in two steps. The first analysis or "train set" will be conducted on the first 150 patients enrolled. The objective is to identify markers associated with mortality at day 28. In a second time, the performance will be confirmed during the "test set".

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Collaborators

Centre Investigation Clinique, Limoges

Registry information

Acronym: TRIAGE

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Apr 15, 2016
Registry last updated: Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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