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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05908162
Other study ID # RRPCEM_SEPSIS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date July 1, 2024

Study information

Verified date June 2023
Source The Republican Research and Practical Center for Epidemiology and Microbiology
Contact Oksana N Romanova, Dr
Phone +375172022505
Email romox@tut.by
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.). Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.


Description:

- analyze biochemical markers and immune status data in sepsis patients and in the comparison group; - assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients; - carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome); - assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process; - based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.


Recruitment information / eligibility

Status Recruiting
Enrollment 89
Est. completion date July 1, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: - age from 1 month to 18 years; - confirmed septic process$ - informed consent. Exclusion Criteria: - age from 18 years; - refuse of patient to participate in the trial; - chronic mental disorders with severe manifestations; - pregnancy/lactation; - intercurrent severe chronic diseases; - HIV, Hepatites B/C; - active tuberculosis; - cachexia of any origin; - malignant neoplasms.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Bood leukocyte subsets
Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils

Locations

Country Name City State
Belarus City Children's Infectious Clinical Hospital Minsk

Sponsors (2)

Lead Sponsor Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary unfavorable course of the sepsis 1 month
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