Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Efferon LPS NEO.
- Who it may be relevant to
- Registry conditions: Burns. Basic parameters: 1 year — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns
Overview
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
Detailed description
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury
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. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.
Primary outcome measures
- ICU length of stay [Time frame: 1-28 days]
Secondary outcome measures (6)
- Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support [Time frame: 1-28 days]
- Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function [Time frame: 1-28 days]
- Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance [Time frame: 1-28 days]
- Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT) [Time frame: 1-28 days]
- Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions [Time frame: 1-28 days]
- Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality [Time frame: 1-28 days]
Eligibility criteria
Inclusion criteria
- Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29)
- Frank index >90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
- Start of hemoadsorption no later than 5 days after admission to the ICU
- The patient should receive adequate infusion therapy (at least 30 mL/kg) from the moment of inclusion in the study until the first sorption
- The patient's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours
Exclusion criteria
- Presence of end-stage renal disease
- Acute pulmonary embolism, confirmed by CT scan
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 2 centers
- Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Heal — Moscow
- Children's municipal multi-specialty clinical center of high medical technology — Saint Petersburg
Identifiers
NCT: NCT07248930 · efferon-lps-2025-03