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NCT Number: NCT05908162

Algorithm for Predicting the Unfavorable Course of Sepsis in Children

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City Children's Infectious Clinical Hospital

Minsk, Belarus

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bood leukocyte subsets

Diagnostic Test

Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils

Other names: assessment of genetic polymorphism

Primary outcomes

  1. Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes

    Time frame: 1 month

    Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes).

    Leucocyte count was determined under a microscope in a Goryaev chamber.

  2. Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)

    Time frame: 1 month

    Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)).

    Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0.

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Collaborators

  • Belarusian State Medical University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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