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Completed

NCT Number: NCT04767893

Diagnostic and Prognostic Biomarkers of Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine - sohag university

Sohag, 82524, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: in the 7th day after appearance of clinical signs of infection

    by turbidimetry

Secondary outcomes

  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

    Time frame: 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

    Time frame: in the 7th day after appearance of clinical signs of infection

    0-<11

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2021
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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