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Recruiting NCT07259668

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

— Observational 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.
Who it may be relevant to
Registry conditions: Burns. Basic parameters: 18 years — 65 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 →

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Official title

An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns

Overview

This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into 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 a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.

Detailed description

Extensive burns represent 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 leading contributors to mortality among severely burned patients.

The Efferon LPS device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which involves a complex systemic inflammatory response. Burn trauma induces the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may lead to the appearance of pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore essential for effective burn injury management. The aim of this study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury.

Interventions

  • Device Efferon LPS
    Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.

Primary outcome measures

  • Effect of the Efferon LPS hemoadsorption on ICU length of stay [Time frame: 1-28 days]
Secondary outcome measures (7)
  • Effect of the Efferon LPS hemoadsorption on need for vasopressor support [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT) [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on incidence of septic complications [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsoption on 28-day mortality [Time frame: 1-28 days]
  • Effect of the Efferon LPS hemoadsoption on length of hospital stay [Time frame: 1-60 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)
  • Burn disease in the stage of acute toxemia or septicemia
  • Frank Index ≥ 90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
  • The patient's condition allows for Efferon LPS therapy for at least 6 hours

Exclusion criteria

  • Isolated thermal inhalation injury
  • Charlson Comorbidity Index > 8
  • Dementia
  • End-stage renal failure
  • Acute pulmonary embolism confirmed by CT
  • Acute myocardial infarction within the past 4 weeks
  • Acute cerebrovascular accident
  • Uncontrolled bleeding (acute blood loss within the past 24 hours)
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study

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 · 1 center
  • State Novosibirsk Regional Clinical Hospital — Novosibirsk

Identifiers

NCT: NCT07259668 · efferon-lps 2025-03.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗