Pro-inflammatory Cytokines Profile and Mortality Rate of Critically Ill Septic Patients Following Plasma Therapeutic Exchange
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- mortality
研究概览
简要总结
Sepsis is one of the most prevalent and fatal diseases in intensive care units .unfortunately, therapeutic approach to sepsis has remained unchanged for many years. Nowadays, the role of cytokines in pathogenesis of sepsis is obvious. Continuous elevated levels of various cytokines in severe sepsis could result in uncontrolled inflammation status. Breaking of inflammatory cascade may lead to improvement in survival. It seems that modulation of inflammation is one of the strategic plans to conquest sepsis. Therefore, elimination of bacterial toxins and pro-inflammatory cytokines from the systemic circulation by plasmapheresis supposed to be rational approach.
Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis treatment. However because of inconsistent results, routine use of this procedure in patients with severe sepsis remains controversial.
The aim of the present survey is to determine the effect of plasmapheresis on plasma levels of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of outcome and treatment of severe sepsis.
详细描述
Method 27 patients with sepsis less than 24 hours, admitted in ICU, 16- 60 years old, male and female, randomized divided two groups(P=12, S=15) study in randomized clinical trial.
Inclusion criteria:
A: At least 3 of SIRS criteria;
- 36> Tem> 38 ◦c
- HR>90 bpm (without medication)
- RR>20 bpm or PaCo2≤ 32 on mechanical ventilation
- WBC<4000 or >12000 or > 10% immature neutrophil
B: Documented diagnosis of sepsis (separation organism from blood, urine, CSF, secretions such as trachea and sore) or strong suspect for infection with at least one of following:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis criteria which were defined by the ACCP/SCCM consensus conference
排除标准
- •Post CPR, pregnant and under 16 years old patients
结局指标
主要结局
mortality
时间窗: 28 days
次要结局
未报告次要终点