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Идёт набор NCT07248930

Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children 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 NEO.
Кому может быть актуально
Состояния в реестре: Burns. Базовые параметры: 1 год — 14 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 NEO Device in Children With Thermal Burns

Обзор

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.

Подробное описание

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

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • ICU length of stay [Срок оценки: 1-28 days]
Вторичные конечные точки (6)
  • Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT) [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions [Срок оценки: 1-28 days]
  • Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality [Срок оценки: 1-28 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)
  • 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

Критерии исключения

  • Presence of end-stage renal disease
  • Acute pulmonary embolism, confirmed by CT scan
  • Uncontrolled bleeding (acute blood loss within the last 24 hours)

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 · 2 центра
  • 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

Идентификаторы

NCT: NCT07248930 · efferon-lps-2025-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗