In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neutrophil phenotype and redistribution
研究概览
简要总结
Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.
The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response.
In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers (18-35 years old)
排除标准
- •Relevant medical history
- •Drug-, nicotine-abuses
- •Tendency towards fainting
- •Hyper- or hypotension
- •Use of any medication
研究组 & 干预措施
C1-esterase inhibitor
C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg
干预措施: C1-esterase inhibitor (Drug)
C1-esterase inhibitor
C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg
干预措施: Endotoxin (Drug)
Placebo
Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg
干预措施: Endotoxin (Drug)
结局指标
主要结局
Neutrophil phenotype and redistribution
时间窗: 8 hrs after LPS administration
次要结局
- Cytokines and other markers of inflammation(8 hrs after LPS administration)
- C1-inhibitor and complement concentration and activity(8 hrs after LPS administration)