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. Decreased sensitivity of bacterial
pathogens to antibiotics, widespread use of invasive methods of diagnosis and treatment,
increased role of opportunistic microorganisms and fungi, increased the number of people
with severe chronic diseases led to an increase in the incidence of sepsis in the period
from 1979 to 2000 by 8.7% annually.
Sepsis is one of the leading causes of hospital mortality in children. Multicenter
studies in pediatric sepsis in various countries 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 in a typical 16-bed PICU, on average there must be at
least one child with sepsis.
In the United States, 75 thousand cases of sepsis in children are recorded annually, and
the mortality rate for severe sepsis is 21%. Importantly, nearly 25% of sepsis survivors
had a clinically significant health-related deterioration in quality of life, with one in
three survivors being discharged with a disability (24% of previously healthy children
were discharged with some form of disability).
In a recent systematic review and meta-analysis of the epidemiology of sepsis, the
incidence of sepsis in children was 48 cases per 100,000 people per year, and septic
shock was 22 cases per 100,000 people per year. In general, the authors determined the
incidence of 1.2 million cases of sepsis in children per year. Mortality in children with
septic shock ranged from 9 to 20%. Significantly, this systematic review did not include
studies from low-income countries where morbidity and mortality from sepsis in children
is likely to be higher.
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: increasing from 6% in patients with dysfunction
of one organ at the time of admission to the ICU to 65% in patients with organ failure of
4 systems or more. Also, lethality is largely determined by the etiology of this
complication. Despite modern advances in antimicrobial chemotherapy, if the etiological
agent of sepsis is gram-negative flora, mortality can reach 75% and the overall prognosis
of patients with endotoxemia and septic shock remains extremely poor.
Hemosorption is a method of extracorporeal removal of toxic substances from the blood by
their sorption on a porous material. Hemosorption can be a good addition or replacement
for classical methods of hemofiltration and hemodialysis, if the diffusion or convection
of toxic substances through the membrane is not efficient enough.
Currently, with the help of hemosorbents based on highly cross-linked
styrene/divinylbenzene copolymers, it is possible to remove endo- and exotoxins of acute
and chronic renal and hepatic failure, eliminate intoxication with pharmacological drugs,
drugs and poisons, and also remove cytokines that are formed in excess during sepsis and
systemic inflammatory syndromes. other etiology.
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 selective LPS 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.
Hemosorption is indicated in patients who suffer from sepsis and are in a state of
sepsis-induced hypotension or "warm shock" despite adequate treatment of the primary site
of infection. The use of hemosorption should be considered justified if there is a threat
of developing sepsis and septic shock, even in the absence of obvious signs of MODS. At
the same time, it is difficult to have an accurate idea of the level of endotoxin in the
patient's blood before conducting selective liposaccharide sorption due to the
methodological difficulties of accurately express determination of the level of LPS in
the blood.
Timely application of the method of multimodal (lipopolysaccharide and cytokine) HP will
reduce the mortality of patients and the number of antibacterial drugs and drugs used to
treat MODS, as well as the length of stay in the ICU and the duration of hospitalization
in general.
The main purpose of this non-interventional study is to obtain data on the efficacy and
safety of using the Efferon LPS NEO medical device for lipopolysaccharide adsorption
during extracorporeal detoxification in children aged 1 month to 14 years with sepsis.
The method of hemosorption technology using a cartridge based on a mesoporous
supercrosslinked styrene-divinylbenzene copolymer 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 the LPS molecule, has been
especially relevant in the last 10 years.
Endotoxin, one of the most potent mediators of sepsis, is found in high concentrations in
approximately 50% of patients with septic shock. Numerous trials have shown that the use
of endotoxin-eliminating extracorporeal sorption techniques improves outcomes in patients
with septic shock.
In patients treated with hemosorption therapy, a rapid improvement in the state according
to the SOFA scale was noted, which led to a decrease in the length of stay in the ICU
compared with patients in the control group. A systematic clinical review of 978 cases
showed that mortality among patients treated with GP using a polymyxin cartridge in
addition to conventional treatment was 33.5% compared with 61.5% in the control group
receiving only conservative anti-infective therapy.
The EUPHAS study, which included 64 patients, showed that the use of the method of
selective sorption of endotoxin using a polymyxin B cartridge can increase 28-day
survival from 47 to 68%, and in-hospital survival from 33 to 59%, i.e., it makes it
possible to reduce mortality in patients with sepsis and septic shock almost 2 times.
Despite the widespread use in recent years of methods for hemosorption of LPS and
cytokines, there are no developed protocols for this type of therapy for pediatric
patients.
Efferon LPS NEO (Efferon Company, Moscow, Russia) is a device for extracorporeal blood
purification using direct hemoperfusion. Detoxification is carried out by selective
adsorption of lipopolysaccharides (bacterial endotoxins) and non-selective adsorption of
cytotoxins with a molecular size of up to 55 kDa (multimodal sorption).
Differences of the multimodal GP method:
the ability to effectively deal with endotoxemia and nonspecific inflammatory
process;
the ability to prevent severe complications and organ damage and increase survival;
the ability to control the course of treatment and quickly respond to changes in the
patient's condition (in contrast to the use of traditional antibacterial drugs);
the ability to significantly reduce the cost of pharmacotherapy and other methods of
treatment, avoid wasteful costs and reduce the length of stay of patients in the ICU
with an overall increase in survival compared to traditional antimicrobial therapy.
Efferon LPS NEO is a cylindrical polycarbonate body filled with spherical granules of
LPS-selective hemosorbent and isotonic sodium chloride solution. The device is
manufactured according to TU 32.50.50-001-12264678-2018, has passed the necessary tests
and is registered in Russia as a medical device RZN 2019/8886 of 06/27/2022.
