NL-OMON31460已完成3 期
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock - PROWESS-SHOCK
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Patient must be an adult (18 years or older)
- •2. Patient must have evidence of an infection for which the patient is receiving intravenous antimicrobial therapy
- •3. Patient must have systemic inflammatory response syndrome (SIRS).
- •4. Patient must have septic shock
- •5. Patients must remain vasopressor dependent throughout the pretreatment period and through the time of randomization
排除标准
- •Patients who, prior to the start of study drug, have received vasopressor therapy (at any dose) for greater than 24 hours or have sepsis-induced organ dysfunction for greater than 36 hours, patients who have had surgery performed within the 12-hour period immediately preceding the study drug infusion, have an active internal bleeding or are at increased risk for bleeding, patients who are not expected to survive 28 days given their preexisting uncorrectable medical condition or are receiving concommitant therapies that will have an impact on their wellbeing
研究者
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