Early Haemadsorption Treatment of Major Burn Trauma Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 7 days mortality
研究概览
简要总结
Major deep burns (>20% body surface, involving deep skin layers) and associated severe inflammatory reaction and their complication are one of the biggest challenge of intensive care. Haemoadsorption therapy, including the CytoSorb treatment is a promising novel therapeutic approach, but only case-studies are available in the literature yet. Based on data from septic shock patient treatment the investigators hypothesize that CytoSorb is beneficial in early treatment of burns. The investigators aim to conduct a randomised-controlled study to assess the clinical effectiveness (based on score systems including MODS, SOFA, APACHE II, KDIGO, ABSI), 7 and 28 days survival, intensive care length of stay, length of mechanical ventilation, resuscitation fluid need and ino/vasopressor drug doses and the presence and severity of organ dysfunctions, particularly renal dysfunction. The investigatora plan to conduct basic research to elucidate the pathophysiological background of clinical effect, including the measurement of inflammatory and anti-inflammatory cytokines, presence and severity of oxidative stress (lipid peroxidation, protein oxidation, reduced/oxidised glutathion levels) and organ dysfunction markers (kidney injury molecule -1, neutrophil gelatinase-associated lipocalin, cystatin-C, uromodulin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent of our patient or next of kin,
- •TBSA >20% with 2/b depth of burn
排除标准
- •non-thermal burn injury,
- •need for acute haemodialysis (intoxication),
- •immunosuppressive treatment, chronic steroid use (> 3 months),
- •known malignant disease,
- •end-stage renal insufficiency or renal transplantation,
- •Child C hepatic cirrhosis,
- •gravidity,
- •potentially lethal burn (Baux index >120) or comorbidities
结局指标
主要结局
7 days mortality
时间窗: Survival rate is assessed in the 7th admission day.
The investigators assess the intensive care and post-intensive care mortality of our patients.
28 days mortality
时间窗: Survival rate is assessed in the 28th admission day.
The investigators assess the intensive care and post-intensive care mortality of our patients.
次要结局
- Levels of inflammatory and anti-inflammatory cytokines during treatment(Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot. Data will be presented in arbitrary units.)
- Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)(Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot.)
- Intensive Care Unit length of stay(Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.)
- Volume resuscitation fluid need of our patients.(Results are summarised daily for our patients during the first week following inclusion.)
- Vasopressor need of our patients.(Results are summarised daily for our patients during the first week following inclusion.)
- Length of mechanical ventilation (if needed).(Length of mechanical ventillation (days). Data is registered through patient discharge from ICU, an average of 1 month.)
- Severity of organ failures according to SOFA point system(Assessed daily for each patient during the first week of our study. Worst results are registered.)