NCT00252915已完成2 期
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
研究概览
简要总结
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.
详细描述
GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis or septic shock,
- •Presence of infection,
- •2 SIRS criteria,
- •Acute organ dysfunction,
- •Immunoparalysis,
- •Informed consent
排除标准
- •Pregnancy,
- •Known allergies to study medication or components,
- •Moribound patient,
- •Autoimmune disease,
- •HIV-infection,
- •Acute MI or pulmonary embolism,
- •Cpr during last 72 hours,
- •Patients who participate in a different clinical study
研究组 & 干预措施
Verum
Experimental
GM-CSF therapy
干预措施: GM-CSF (verum) (Biological)
结局指标
主要结局
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
时间窗: after therapy
次要结局
未报告次要终点
研究者
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