2023-503946-30-00招募中4 期
A randomized study to investigate central and cerebral hemodynamic effects and volume kinetics of Ringer´s Acetate compared with no intravenous fluids, during experimental hypovolemia compared with euvolemia, in healthy human volunteers.
Oslo University Hospital HF1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年6月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Half-life of cardiac stroke volume relative to baseline
研究概览
简要总结
To assess the duration of hemodynamic effect of bolus Ringer`s acetate
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound
- •Female participants: Use of adequate birth control for women of childbearing potential
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted)
- •Breastfeeding
- •History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted)
- •Any known cardiac arrhythmia
- •Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted)
结局指标
主要结局
Half-life of cardiac stroke volume relative to baseline
Half-life of cardiac stroke volume relative to baseline
次要结局
- Half-life of intravascular volume relative to baseline
- Half-life of MCAv integral relative to baseline
研究者
Principal investigator
Scientific
Oslo University Hospital HF
研究点 (1)
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