Algorithm for Predicting the Unfavorable Course of Sepsis in Children

Study Overview
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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.

Official Title
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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

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: Bood leukocyte subsets


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with sepsis on day 1<br> | Diagnostic Test: Bood leukocyte subsets<br>* Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils<br>* Other names: assessment of genetic polymorphism;|
| Patients with sepsis on day 7<br> | Diagnostic Test: Bood leukocyte subsets<br>* Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils<br>* Other names: assessment of genetic polymorphism;|
| Patients with severe bacterial infection<br> | Diagnostic Test: Bood leukocyte subsets<br>* Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils<br>* Other names: assessment of genetic polymorphism;|
| Patients with severe viral infection<br> | Diagnostic Test: Bood leukocyte subsets<br>* Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils<br>* Other names: assessment of genetic polymorphism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unfavorable course of the sepsis |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, monocytes, neutrophils, genetic polymorphism, PDRF