NCT00818597已完成1 期
PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
University of Rostock2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2003年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- single organ functions (circulation, kidney, lung, liver)
研究概览
简要总结
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •sepsis with at least one organ failure (severe sepsis) or septic shock
排除标准
- •Participation in another study within the last 30 days
- •Earlier participation in this study
- •Pregnancy
- •Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
- •Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy
- •HIV infection
- •HCV infection, active
结局指标
主要结局
single organ functions (circulation, kidney, lung, liver)
时间窗: 28day post inclusion
次要结局
- survival(28day post inclusion)
研究者
研究点 (2)
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