Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children 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.

Conditions

• Sepsis
• Septic Shock

Interventions

DEVICE

Efferon LPS NEO

Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. The device is used for extracorporeal therapy to relieve septic shock in the treatment of sepsis.

Sponsors & Collaborators

• Ligand Research, LLC

  collaborator NETWORK

• Efferon JSC

  lead INDUSTRY

Principal Investigators

• Sergei Stepanenko, PhD, MD · Filatov Children's City Clinical Hospital of the Moscow Health Department

• Igor Afukov, PhD, MD · Filatov Children's City Clinical Hospital of the Moscow Health Department

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2025-03-03

Completion

2025-04-30

Countries

• Russia

Study Locations