To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers

Recruiting

• Conditions: Sepsis

• Registration Number: NCT06142162
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Brief Summary

Current study evaluates the relationship between cell immunity, biochemical and genetic markers in patients with sepsis in order to develop algorithm for predicting the course and outcome of severe bacterial infections.

Detailed Description

* To study the state of the immune system in patients with sepsis: the content of blood monocyte subpopulations (classical, intermediate and non-classical monocytes), HLA-DR expression on monocytes, CD64 expression on neutrophils, spontaneous and stimulated production of reactive oxygen species by blood neutrophils etc.;

* To study biochemical blood parameters and genetic polymorphism of immune response genes;

* To evaluate the relationship between genetic features of the patient's immune system, biochemical blood parameters, immune system cells and the severity of the pathological process.

* To develop an algorithm to prevent the development of sepsis in children.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2); availability of written informed consent of the patient's legal representatives for the study.

Exclusion Criteria

acute and chronic heart failure; renal failure; acute and chronic liver failure; acute and chronic leukemia, severe anemia; HIV infection; immunosuppressive therapy; malignant neoplasms

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
genes polymorphism	3 years	TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes polymorphism
monocytes	3 years	proportion of classical monocytes (CD14++CD16-), intermediate monocytes (CD14++CD16+) and non-classical monocytes (CD14+/-CD16++); HLA-DR level of expression
neutrophils	3 years	percentage of CD64+ neutrophils and CD64 level of expression
cytokines levels in the serum	3 years	TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum

Trial Locations

Locations (1)

Republican Research and Practical Centre for Epidemiology and Microbiology; 🇧🇾 Minsk, Belarus