An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effect of the Efferon LPS hemoadsorption on ICU length of stay
研究概览
简要总结
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.
详细描述
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.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 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)
- •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
排除标准
- •Isolated thermal inhalation injury
- •Charlson Comorbidity Index > 8
- •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
结局指标
主要结局
Effect of the Efferon LPS hemoadsorption on 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 hemoadsorption on need for vasopressor support(1-28 days)
- Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function(1-28 days)
- Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions(1-28 days)
- Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)(1-28 days)
- Effect of the Efferon LPS hemoadsorption on incidence of septic complications(1-28 days)
- Effect of the Efferon LPS hemoadsoption on 28-day mortality(1-28 days)
- Effect of the Efferon LPS hemoadsoption on length of hospital stay(1-60 days)