Pilot Prospective Randomized Controlled Study of Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU in Comparison With the Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Vasopressor dose reduction
研究概览
简要总结
To assess the efficiency and safety of combined extracorporeal blood purification in patients with septic shock in Neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT).
详细描述
According to studies and modern sepsis treatment guidelines, conventional CRRT has not proved effective in the septic shock treatment.
Effectiveness of other extracoporeal blood purification methods, such as hemoadsorption or combined blood purification (hemoadsorption combined with CRRT) is widely pointed out in current publications: contemporary studies in general ICU patients demonstrated that the use of hemoadsorption or combined extracorporeal blood purification methods is effective for septic shock patients treatment.
It has been proven that cytokines discharged into the systemic blood flow are the key pathophysiological mechanism of septic shock. Hemoadsorption allows for significantly more effective removal of different inflammatory mediators than the traditional methods of CRRT. The combined extracorporeal blood purification method demonstrated similar efficacy in general ICU patients.
The aim of this study is to assess the efficiency and safety of combined extracorporeal blood purification in with septic shock in neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT) with AN69 membrane.
Study novelty: We have not encountered published studies evaluating the efficiency of combined extracorporeal blood purification methods in neurosurgical patients with septic shock. Furthermore, currently there is not enough data to compare combined extracorporeal blood purification with CRRT for septic shock treatment. The planned study is the first to investigate the safety and efficiency of combined extracorporeal blood purification in patients with septic shock in neurosurgical ICU.
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
- Single (Participant)
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
- •diagnosis of septic shock according to SEPSIS 3 definition
- •Glasgow Coma Scale of 4 and more on admission
- •invasive hemodynamics monitoring
- •norepinephrine > 0,1 µg/kg/min or use of 2 vasopressors
排除标准
- •age <18 years
- •>24 hours after diagnosis of septic shock
结局指标
主要结局
Vasopressor dose reduction
时间窗: 6, 12, 24, 48 and 72 hours after the randomization time
Vasopressor dose reduction value
Time on vasopressor support
时间窗: Up to 28 days after the randomization date
Time on vasopressor support
SOFA score reduction
时间窗: 24, 48 and 72 hours after the randomization time
SOFA score reduction
次要结局
- Hospital stay time(up to 3 months after the randomization date)
- Mechanical ventilation time(up to 3 months after the randomization date)
- C - reactive protein level reduction(24, 48 and 72 hours after the randomization time)
- Arteriovenous pCO2 gap reduction(6, 12, 24, 48 and 72 hours after the randomization time)
- Interleukins concentration reduction(6, 12, 24 and 48 hours after the randomization time)
- Tumor necrosis factor-α concentration reduction(6, 12, 24 and 48 hours after the randomization time)
- PiCCO-derived parameters normalization(6, 12, 24, 48 and 72 hours after the randomization time)
- Procalcitonin concentration reduction(6, 12, 24, 48 and 72 hours after the randomization time)
- Total bilirubin concentration reduction(6, 12, 24 and 48 hours after the randomization time)
- Arterial blood lactate level reduction(6, 12, 24, 48 and 72 hours after the randomization time)
- ICU length of stay(up to 3 months after the randomization date)
- Continuous renal replacement therapy time(up to 3 months after the randomization date)