NCT00190788已完成3 期
A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- - To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension
研究概览
简要总结
The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.
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
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
- •Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- •Continue requirement of Vasopressor support after 96 hour commercial infusion
排除标准
- •Patients require extensive surgical procedures within next 3 days
- •Patients with platelet count below 30,000/mm3
- •Patients receiving therapeutic heparin of 15,000 units/day and more
- •Patients not expected to survive 24 days
- •Patients contraindicated as to the country specific registration
结局指标
主要结局
- To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension
次要结局
- Investigate safety profile of an extended infusion of DDA
- Evaluate Reduction of 28-day all cause mortality
- Evaluate effects on various organ functions over 14 days
- Evaluate effects on the concentration of various biomarkers
研究者
研究点 (3)
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