NCT04767893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

February 16, 2021

Last Update Submit

February 21, 2021

Conditions

Sepsis

Keywords

sTREM-1sUPARCRP

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study was conducted on patients admitted to different ICUs in Sohag University Hospital who develop possible clinical signs of sepsis

You may qualify if:

  • 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

You may not qualify if:

  • HIV patients
  • Patients with neutropenia \<1000 cells/mm3
  • \<18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine - sohag university

Sohag, 82524, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nahed Fathallah, lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of medical microbiology & immunology departement -faculty of medicine

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

June 14, 2019

Primary Completion

December 1, 2020

Study Completion

December 28, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

EG(1)