Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Half life of Copeptin
研究概览
简要总结
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers
详细描述
Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum Age 18
- •no severe comorbidities
- •no medication (except contraceptives)
- •baseline sodium Level 135-145mmol/l
- •euvolemic status
排除标准
- •history of heart failure
- •liver cirrhosis
- •kidney disease (GFR <60ml/min)
- •uncontrolled Hypertension
- •pregnancy
- •Diabetes mellitus
- •BMI >28kg/m2
- •other severe disease
结局指标
主要结局
Half life of Copeptin
时间窗: beginning and end of protocol, up to 8 hours
Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion)
Physiological relationship between Serum osmolality and Plasma copeptin release.
时间窗: beginning and end of protocol, up to 8 hours
Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l). Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states.
次要结局
未报告次要终点
研究者
Mirjam Christ-Crain
Prof. Dr. med.
University Hospital, Basel, Switzerland