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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Bood leukocyte subsets

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.

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus
    • City Children's Infectious Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe viral infection, with sepsis on day 1 and day 7

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with sepsis on day 1	Diagnostic test: Bood leukocyte subsets; Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils; Other Names: assessment of genetic polymorphism
Patients with sepsis on day 7	Diagnostic test: Bood leukocyte subsets; Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils; Other Names: assessment of genetic polymorphism
Patients with severe bacterial infection; Patients with severe bacterial infection (pneumonia)	Diagnostic test: Bood leukocyte subsets; Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils; Other Names: assessment of genetic polymorphism
Patients with severe viral infection; Patients with severe viral infection (COVID19)	Diagnostic test: Bood leukocyte subsets; Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils; Other Names: assessment of genetic polymorphism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes	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.	1 month
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)	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.	1 month

Collaborators and Investigators

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
• Collaborators: Belarusian State Medical University
• Investigators: Principal Investigator: Elena G Fomina, Dr, The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sepsis; monocytes; neutrophils; genetic polymorphism; PDRF
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: RRPCEM_SEPSIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No