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NCT05908162

Algorithm for Predicting the Unfavorable Course of Sepsis in Children

NCT ID: NCT05908162

Last Updated: 2025-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-01-01

Brief Summary

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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

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* 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

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Sepsis

Keywords

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Sepsis monocytes neutrophils genetic polymorphism PDRF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with sepsis on day 1

Patients with sepsis on day 1

Bood leukocyte subsets

Intervention Type DIAGNOSTIC_TEST

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

Patients with sepsis on day 7

Patients with sepsis on day 7

Bood leukocyte subsets

Intervention Type DIAGNOSTIC_TEST

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

Patients with severe bacterial infection

Patients with severe bacterial infection (pneumonia)

Bood leukocyte subsets

Intervention Type DIAGNOSTIC_TEST

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

Patients with severe viral infection

Patients with severe viral infection (COVID19)

Bood leukocyte subsets

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Bood leukocyte subsets

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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assessment of genetic polymorphism

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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E.G.Fomina

Head of the Laboratory for Immunology and Cellular Biotechnology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena G Fomina, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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City Children's Infectious Clinical Hospital

Minsk, , Belarus

Site Status

Countries

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Belarus

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

Other Identifiers

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RRPCEM_SEPSIS

Identifier Type: -

Identifier Source: org_study_id

NCT06142162

Identifier Type: -

Identifier Source: nct_alias