Clinical trial NCT05908162: Algorithm for Predicting the Unfavorable Course of Sepsis in Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Sepsis
monocytes
neutrophils
genetic polymorphism
PDRF
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
Collaborators: name: Belarusian State Medical University
First posted: 2023-06-18
Enrollment: 89
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe viral infection, with sepsis on day 1 and day 7

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: unfavorable course of the sepsis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: City Children's Infectious Clinical Hospital
Study officials:
affiliation: The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)
name: Elena G Fomina, Dr
role: PRINCIPAL_INVESTIGATOR
References: