Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis - Trial NCT05707494

Timeline & Enrollment

Primary Outcome

Effect of Efferon LPS NEO Hemoperfusion on pSOFA (pediatric Sequential Organ Failure Assessment) Scores in Patients with Sepsis

Summary

One of the major health problems in the world is sepsis, the number of cases of which,
 according to WHO, annually reaches 20-30 million. The decrease in the sensitivity of
 bacterial pathogens to antibiotics, the widespread use of invasive diagnostic and treatment
 methods, the increased role of opportunistic microorganisms and fungi, and the increase in
 the number of people with severe chronic diseases led to an increase in the incidence of
 sepsis in the period from 1979 to 1979. 2000 by 8.7% per annum.
 
 Sepsis is one of the leading causes of hospital mortality in children. Multicenter
 cross-country studies of pediatric sepsis using a prospective methodology in nearly 7,000
 children (mean age 3 years) in 128 pediatric intensive care units (ICUs) in 26 different
 countries showed that a typical 16-bed intensive care unit should have, on average, at least
 one child with sepsis.
 
 Sepsis and septic shock in most cases are accompanied by the development of multiple organ
 failure syndrome (MODS). The frequency of adverse outcomes directly depends on the number of
 organ systems involved in MODS: it increases from 6% in patients with dysfunction of one
 organ at the time of admission to the intensive care unit to 65% in patients with organ
 failure of 4 systems or more. Despite modern advances in resuscitation and antimicrobial
 chemotherapy, if the etiological agent of sepsis is gram-negative flora, mortality can reach
 75%.
 
 Numerous studies have shown that the use of extracorporeal sorption methods that eliminate
 endotoxin improves the results of treatment of patients with septic shock. The use of LPS
 selective adsorption is both an etiological and pathogenetic method of treatment, which
 justifies the need for its use in the complex intensive care of sepsis and septic shock.
 
 The method of hemosorption technology using a cartridge based on a mesoporous
 supercrosslinked copolymer of styrenedivinylbenzene with an LPS-selective ligand immobilized
 on the surface, which has the ability to neutralize the biological activity of endotoxin by
 binding lipid A, the main pathogenic site of LPS. the molecule matters.
 
 The main goal of the study was to obtain data on the efficacy and safety of using the Efferon
 LPS NEO hemosorption column for the adsorption of lipopolysaccharides during extracorporeal
 detoxification in children aged 1 month to 14 years with sepsis.

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