Diagnostic and Prognostic Biomarkers of Sepsis

Study Overview
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Brief Summary
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This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.

Detailed Description
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Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients

Official Title
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Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Temperature of >38oC Heart rate of >90 beats/min Respiratory rate of >20 breaths/min Partial pressure of arterial carbon dioxide (PaCO2) of <32 mmHg White blood cell (WBC) count of >12,000 cells/mm3 Exclusion Criteria: HIV patients Patients with neutropenia <1000 cells/mm3 <18 years of age.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS | by ELISAenzyme linked immunosorbent assay | in the 1st day after appearance of clinical signs of infection | 
| Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS | by ELISAenzyme linked immunosorbent assay | in the 7th day after appearance of clinical signs of infection | 
| Measurement of the serum level of sUPAR (ng/L) in the ICU patients | by ELISAenzyme linked immunosorbent assay | in the 1st day after appearance of clinical signs of infection | 
| Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS | by ELISAenzyme linked immunosorbent assay | in the 7th day after appearance of clinical signs of infection | 
| Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS | by turbidimetry | in the 1st day after appearance of clinical signs of infection | 
| Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS | by turbidimetry | in the 7th day after appearance of clinical signs of infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS | an integer score from 0 to 71 | in the 7th day after appearance of clinical signs of infection | 
| The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS | 0-<11 | in the 7th day after appearance of clinical signs of infection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, sTREM-1, sUPAR