Inflammation and the Host Response to Injury (In Healthy Volunteers)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Physiological, Hematological, Immunological Responses
研究概览
简要总结
The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.
详细描述
The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
- •Written informed consent prior to the performance of any study related procedure.
排除标准
- •History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
- •Recent history of alcohol or drug abuse
- •Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
- •Exposure to any experimental agent or procedure within 30 days of study
- •Pregnancy or breast feeding
- •Prior exposure to endotoxin in an experimental setting -
结局指标
主要结局
Physiological, Hematological, Immunological Responses
时间窗: .5-24 hours after Endotoxin administration
次要结局
未报告次要终点