NCT05908162

Algorithm for Predicting the Unfavorable Course of Sepsis in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bood leukocyte subsets	Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-25
• Completion: 2025-01-01
• First posted: 2023-06-18
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

1 site across 1 country: Belarus