Algorithm for Predicting the Unfavorable Course of Sepsis in Children

NCT05908162 | Completed Results

• 1 other identifier: RRPCEM_SEPSIS
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; monocytes; neutrophils; genetic polymorphism; PDRF

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Patients with sepsis on day 1

Patients with sepsis on day 1

Diagnostic Test: Bood leukocyte subsets

Patients with sepsis on day 7

Patients with sepsis on day 7

Diagnostic Test: Bood leukocyte subsets

Patients with severe bacterial infection

Patients with severe bacterial infection (pneumonia)

Diagnostic Test: Bood leukocyte subsets

Patients with severe viral infection

Patients with severe viral infection (COVID19)

Diagnostic Test: Bood leukocyte subsets

Interventions

Bood leukocyte subsets DIAGNOSTIC_TEST

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

Also known as: assessment of genetic polymorphism

Patients with sepsis on day 1; Patients with sepsis on day 7; Patients with severe bacterial infection; Patients with severe viral infection

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age from 1 month to 18 years;
• confirmed septic process$
• informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Republican Research and Practical Center for Epidemiology and Microbiology: lead
• Belarusian State Medical University: collaborator

Study Sites (1)

City Children's Infectious Clinical Hospital

Minsk, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood, serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head of laboratory Fomina E.G.
• Organization: Republican center of Hygiene, Epidemiology and Public Health

feg1@tut.by

+375173740417

Study Officials

• Elena G Fomina, Dr

  The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory for Immunology and Cellular Biotechnology

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2021
• Primary Completion: December 25, 2024
• Study Completion: January 1, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)