Diagnostic and Prognostic Biomarkers of Sepsis

NCT ID: NCT04767893

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-14

Study Completion Date

2020-12-28

Brief Summary

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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

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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

Conditions

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Sepsis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nahed Fathallah Fahmy

lecturer of medical microbiology & immunology departement -faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahed Fathallah, lecturer

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Faculty of medicine - sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-21-02-18

Identifier Type: -

Identifier Source: org_study_id

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