Algorithm for Predicting the Unfavorable Course of Sepsis in Children

The Republican Research and Practical Center for Epidemiology and Microbiology

Status: Completed

Conditions: Sepsis

Treatments: Diagnostic Test: Bood leukocyte subsets

Study type: Observational

Funder types: Other

Identifiers

NCT05908162

RRPCEM_SEPSIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

185 participants in 4 patient groups

Patients with sepsis on day 1

Description:

Patients with sepsis on day 1

Treatment:

Diagnostic Test: Bood leukocyte subsets

Patients with sepsis on day 7

Description:

Patients with sepsis on day 7

Treatment:

Diagnostic Test: Bood leukocyte subsets

Patients with severe bacterial infection

Description:

Patients with severe bacterial infection (pneumonia)

Treatment:

Diagnostic Test: Bood leukocyte subsets

Patients with severe viral infection

Description:

Patients with severe viral infection (COVID19)

Treatment:

Diagnostic Test: Bood leukocyte subsets