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Идёт набор NCT07259668

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

— Наблюдательное Burns

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Efferon LPS.
Кому может быть актуально
Состояния в реестре: Burns. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Effect of the Efferon LPS hemoadsorption on ICU length of stay [Срок оценки: 1-28 days]
Вторичные конечные точки (7)
  • Effect of the Efferon LPS hemoadsorption on need for vasopressor support [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT) [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on incidence of septic complications [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsoption on 28-day mortality [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS hemoadsoption on length of hospital stay [Срок оценки: 1-60 days]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Россия · 1 центр
  • State Novosibirsk Regional Clinical Hospital — Novosibirsk

Идентификаторы

NCT: NCT07259668 · efferon-lps 2025-03.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗