Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Patients With Severe Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference of serum interleukin-6 level
研究概览
简要总结
In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.
Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all criteria (A+B+C):
- •A) Identified infection source under adequate treatment
- •B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
- •C) Severe septic shock (serum lactate > 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is > 0.2 mcg/kg/min for more than 1 hour or >0.1 mcg/kg/min for more than 3 hours )
排除标准
- •Onset of severe septic shock more than 24 hours
- •Received continuous renal replacement therapy within 24 hours before enrollment
- •Serum white blood cell count count < 1000 cells/μL or Platelet count < 50000 cells/μL
- •History of allergy to heparin
- •Received cardiopulmonary resuscitation within 4 weeks before enrollment
- •ICU admission due to severe septic shock within 2 months
- •Patients or Family had chosen palliative care and signed an agreement to deny aggressive treatment
- •Pregnancy
- •APACHE II Score > 30 at enrollment
- •Non-native speakers
结局指标
主要结局
Difference of serum interleukin-6 level
时间窗: 24 hours
Comparison to enrollment or between 2 groups
次要结局
- Difference of serum interleukin-10 level(72 hours)
- Difference of mean arterial pressure(72 hours)
- Difference of norepinephrine infusion rate(72 hours)
- Difference of serum procalcitonin level(72 hours)
- Difference of serum interleukin-1β level(72 hours)
- Difference of cardiac output(72 hours)
- Difference of the sequential organ failure assessment score(72 hours)
- Difference of serum endocan level(72 hours)
- Difference of serum interleukin-6 level(72 hours)
- Difference of daily IV fluids(72 hours)
- Difference of serum diamine oxidase level(72 hours)