Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis

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.

Inclusion Criteria:Weight from 5 kg. up to 40 kg (main criterion),Age from 1 month to 14 years,No more than 12 hours from the moment of establishment of DZ - Sepsis in accordance with the criteria of SEPSIS-3 (2016, modified for childhood), most likely, Gr-etiology, at the time of inclusion.The immediate postoperative period in case of abdominal nature of sepsis (no more than 12 hours after surgery),If the patient has a focus of surgical infection, then it should be sanitized,pSOFA scale ≥ 6 points, or an increase in negative dynamics on the pSOFA scale by 2 or more points over 12 hours of observation,The patient's condition allows for therapy with the Efferon LPS NEO column for at least 4 hours.Exclusion Criteria:Weight below 5 kg and over 40 kg,Age less than 1 month and over 14 years old,Failure to obtain informed consent from the patient's parents, family member or legal representative,The presence of a focus of non-sanitized surgical infection,Use in the treatment of other methods of extracorporeal removal of LPS and inflammatory mediators (hemofilters with highly permeable and surface-modified membranes),Acute pulmonary embolism,Intracranial hemorrhage or bleeding tendency in general,Induced aplasia of hematopoiesis,If it is impossible to provide vascular access necessary for the method,Any other condition that, in the opinion of the Investigator, would prevent the patient from being a suitable candidate for inclusion in the trial (for example, a chronic disease in the terminal stage or a mental disorder that affects the methodology for conducting a hemoperfusion procedure, as well as for patients who have a "palliative status ").