Clincosm LogoSign in Get a demo

Diagnostic and Prognostic Biomarkers of Sepsis

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04767893
Collaborator
(none)
67
Enrollment
1
Location
18.5
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    67 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients
    Actual Study Start Date :
    Jun 14, 2019
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Dec 28, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS [in the 1st day after appearance of clinical signs of infection]

      by ELISA"enzyme linked immunosorbent assay"

    2. 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"

    3. 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"

    4. 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"

    5. Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS [in the 1st day after appearance of clinical signs of infection]

      by turbidimetry

    6. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine - sohag university Sohag Egypt 82524

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Nahed Fathallah, lecturer, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nahed Fathallah Fahmy, lecturer of medical microbiology & immunology departement -faculty of medicine, Sohag University
    ClinicalTrials.gov Identifier:
    NCT04767893
    Other Study ID Numbers:
    • Soh-Med-21-02-18
    First Posted:
    Feb 23, 2021
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nahed Fathallah Fahmy, lecturer of medical microbiology & immunology departement -faculty of medicine, Sohag University
    sTREM-1
    sUPAR
    CRP
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Feb 23, 2021