Diagnostic and Prognostic Biomarkers of Sepsis

Completed

• Conditions: Sepsis

• Registration Number: NCT04767893
• Lead Sponsor: Sohag University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2019-06-14
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-28
• Status Verified: 2021-02
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS	in the 7th day after appearance of clinical signs of infection	by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS	in the 7th day after appearance of clinical signs of infection	by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of sUPAR (ng/L) in the ICU patients	in the 1st day after appearance of clinical signs of infection	by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS	in the 7th day after appearance of clinical signs of infection	by turbidimetry

Secondary Outcome Measures

Name	Time	Method
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	in the 7th day after appearance of clinical signs of infection	an integer score from 0 to 71
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	in the 7th day after appearance of clinical signs of infection	0-\<11

Trial Locations

Locations (1)

Faculty of medicine - sohag university; 🇪🇬 Sohag, Egypt