Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis

NCT05707494 | Completed DMC

• 1 other identifier: efferon-lps-2023-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

septic shock; sepsis; extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (1)

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

  The value of indicators on the pSOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 7 days. The pSOFA score was developed using validated age-adjusted cut points for the cardiovascular and renal criteria from the second Pediatric Logistic Organ Dysfunction (PELOD-2) scoring system. Scores were calculated daily from admission to the PICU until day 7 of stay, discharge, or death, whichever came first.The pSOFA index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. The lower the pSOFA index, the less pronounced organ failure and the better the patient's survival prognosis.

  1-7 days

Secondary Outcomes (5)

• Effect of Efferon LPS NEO hemoperfusion on systemic hemodynamic parameters after initiation of use in patients with sepsis complicated by septic shock

  1-72 hours

• Influence of hemoperfusion Efferon LPS NEO in extracorporeal therapy of patients with complicated sepsis septic shock

  1-14 days

• Effect of LPS NEO Efferon hemoperfusion on endotoxin activity

  1-72 hours

• Effect of the Efferon LPS NEO hemoperfusion on pulmonary oxygen metabolism function

  1-72 hours

• Effect of the Efferon LPS NEO hemoperfusion on the length of stay in the PICU

  1-14 days

Study Arms (2)

Basic therapy + Efferon LPS NEO

EXPERIMENTAL

Study group: Basic therapy + Efferon LPS NEO - 32 patients, prospective enrollment.

Device: Efferon LPS NEO

Baseline therapy

NO INTERVENTION

Control group: Basic therapy - 46 patients, retrospective enrollment. Basic therapy is the routine practice of the institution for the treatment of patients with sepsis (conservative anti-infective therapy). Antibacterial therapy regimens, antibiotic dosage adjustment regimens for AKI and prolonged RRT procedures are not specifically prescribed in the CT Plan.

Interventions

Efferon LPS NEO DEVICE

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.

Basic therapy + Efferon LPS NEO

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight from 5 kg. up to 40 kg (main criterion),
• Age from 1 month to 14 years,
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Efferon JSC: lead
• Ligand Research, LLC: collaborator

Study Sites (7)

Children's City Clinical Hospital named after St. Vladimir of the Moscow Department of Health

Moscow, 107014, Russia

Location

Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department

Moscow, 119049, Russia

Location

Clinical and Research Institute of Emergency Pediatric Surgery and Traumatology

Moscow, 119180, Russia

Location

Filatov Children's City Clinical Hospital of the Moscow Health Department

Moscow, 123001, Russia

Location

Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department

Moscow, 123317, Russia

Location

Children's City Clinical Hospital No. 5 named after N.F.Filatov

Saint Petersburg, 192289, Russia

Location

Children's municipal multi-specialty clinical center of high medical technology

Saint Petersburg, 198205, Russia

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sergei Stepanenko, PhD, MD

  Filatov Children's City Clinical Hospital of the Moscow Health Department

  PRINCIPAL INVESTIGATOR

• Igor Afukov, PhD, MD

  Filatov Children's City Clinical Hospital of the Moscow Health Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter prospective observational study with a control group to evaluate the efficacy and safety of LPS Adsorption using the Efferon LPS NEO device in children with SepSis (LASSO NEO).

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 1, 2023
• Study Start: January 1, 2023
• Primary Completion: March 3, 2025
• Study Completion: April 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

RU (7)