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NCT Number: NCT07259668

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location status: Recruiting

Location contact

Igor Samatov, PhD, MD

CONTACT

[email protected]

+79139084409

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efferon LPS

Device

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 outcomes

  1. Effect of the Efferon LPS hemoadsorption on ICU length of stay

    Time frame: 1-28 days

    Time (days) from the start of hemoadsorption to transfer from the ICU

Secondary outcomes

  1. Effect of the Efferon LPS hemoadsorption on need for vasopressor support

    Time frame: 1-28 days

    Need for vasopressors according to the VIS 2020 scale (Vasoactive-Inotropic Score), a weighted sum of vasoactive and inotropic medication doses; higher scores indicate greater hemodynamic support requirement (worse outcome).

  2. Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function

    Time frame: 1-28 days

    Value of oxygenation index (PaO₂/FiO₂ (Pa))

    Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).

  3. Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)

    Time frame: 1-28 days

    Duration of renal replacement therapy (RRT) in hours

  4. Effect of the Efferon LPS hemoadsorption on incidence of septic complications

    Time frame: 1-28 days

    Frequency of septic complications

  5. Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions

    Time frame: 1-28 days

    Frequency of surgical interventions

  6. Effect of the Efferon LPS hemoadsoption on 28-day mortality

    Time frame: 1-28 days

    Mortality rate

  7. Effect of the Efferon LPS hemoadsoption on length of hospital stay

    Time frame: 1-60 days

    Length of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

[email protected]

+79636564765

Sponsors and collaborators

Lead sponsor

Efferon JSC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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