An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ICU length of stay
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of end-stage renal disease
- •Acute pulmonary embolism, confirmed by CT scan
- •Uncontrolled bleeding (acute blood loss within the last 24 hours)
结局指标
主要结局
ICU length of stay
时间窗: 1-28 days
Time (days) from the start of hemoadsorption to transfer from the ICU
次要结局
- Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support(1-28 days)
- Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function(1-28 days)
- Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance(1-28 days)
- Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)(1-28 days)
- Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions(1-28 days)
- Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality(1-28 days)