N/A
Completed N=185
Algorithm for Predicting the Unfavorable Course of Sepsis in Children
Source: ClinicalTrials.gov NCT05908162 ↗Enrolled (actual)
185
Serious AEs
1.6%
Results posted
Dec 2025
Primary outcomePrimary: Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes — 16.0; 11.2; 11.9; 4.9 10^9 cells/l — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes |
16.0; 11.2; 11.9; 4.9; 6.9; 1.83 | <0.05 sig |
| PRIMARY Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %) |
15.2; 30.3; 15.7; 24.9; 44.5; 67.4 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT05908162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.