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NCT04767893 Clinical Trial

Diagnostic and Prognostic Biomarkers of Sepsis

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04767893
Other study ID # Soh-Med-21-02-18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2019
Est. completion date December 28, 2020

Study information
Verified date February 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date December 28, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Faculty of medicine - sohag university Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS by ELISA"enzyme linked immunosorbent assay" in the 1st day after appearance of clinical signs of infection
Primary Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS by ELISA"enzyme linked immunosorbent assay" in the 7th day after appearance of clinical signs of infection
Primary Measurement of the serum level of sUPAR (ng/L) in the ICU patients by ELISA"enzyme linked immunosorbent assay" in the 1st day after appearance of clinical signs of infection
Primary Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS by ELISA"enzyme linked immunosorbent assay" in the 7th day after appearance of clinical signs of infection
Primary 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
Primary 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 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
Secondary 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
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