An observational study in Sepsis and Severe Sepsis, sponsored by BioMérieux. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by BioMérieux · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 602 is above the median of 160 across 929 observational studies indexed under Sepsis.
Browse Sepsis studies →BioMérieux is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient freshly admitted to Emergency department
Exclusion Criteria:
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
Time frame: Up to 72 hours after admission
patient status at D28 (alive or death)
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".
Time frame: Up to 28 days after admission
Plan to share: Yes
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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