Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- inflammation
研究概览
简要总结
Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha.
Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
- •Within 48 hour diagnose sepsis
- •Agree to participate
排除标准
- •Pregnancy and lactation
- •Severe thrombocytopenia, platelet less than 30.000/mm3
- •Bleeding or high risk of major bleeding
- •During anticoagulant treatment
- •After thrombolytic treatment
- •Decompensated chronic liver diseases
- •Chronic kidney diseases on dialysis treatment
- •During high dose corticosteroid treatment
- •HIV with CD4 count below 50/mm3
- •Indication for high dose heparin treatment
研究组 & 干预措施
Unfractionated Heparin
Low dose unfractionated Heparin 10 unit/kgBW/hour continuous infusion
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
inflammation
时间窗: 3 days
determine effects of low dose unfractionated heparin treatment on nuclear factor kappa B, inhibitor kappa B kinase and tumor necrosis factor-alpha.
次要结局
- clinical outcome(14 days)