Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of volunteers with acute mountain sickness
研究概览
简要总结
The trial investigates changes in metabolism during high altitude expedition up to 6865m. A mass-spectrometry based platform is used to detect different oxidative stress related metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory parameters.
详细描述
Background
Altitude related illness, which include acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE), is common in subjects exposed to high altitude during professional or leisure time activities. There are independent risk factors such as: individual susceptibility and rate of ascent. HAPE is a potentially life-threatening complication of high altitude stay, mostly occuring within the first 2-5 days of exposure. Although there is a controversial discussion, excessive hypoxic pulmonary vasoconstriction is thought to be the main trigger for developing HAPE. Beside the controversial discussion if hypobaric hypoxia leads to oxidative stress it is not known whether oxidative stress contributes to AMS or HAPE.
Objective
The investigators hypothesize that reactive oxygen species are generated during high altitude stay and contribute to the development of acute mountain sickness. Furthermore they would like to describe other changes in metabolic pathways possibly contributing to vessel tone dysregulation.
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physical fit
- •mountaineering experience
- •18-70 years
排除标准
- •any type of disease
- •regular intake of medicaments
- •history of high altitude pulmonary edema
- •severe acute mountain sickness below an altitude of 3500m
- •any history of high altitude cerebral edema
结局指标
主要结局
Number of volunteers with acute mountain sickness
时间窗: during ascent, expected to be approximately 19-23 days
次要结局
- Change from baseline in oxygen saturation in blood(during ascent, expected to be approximately 19-23 days)
- Changes from baseline in different metabolic pathways(during ascent, expected to be approximately 19-23 days)
- Changes from baseline in oxidative stress(during ascent, expected to be approximately 19-23 days)