Algorithm for Predicting the Unfavorable Course of Sepsis in Children

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908162
• Other study ID #: RRPCEM_SEPSIS
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

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