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临床试验/NCT00332267
NCT00332267已完成不适用

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年5月最近更新:
适应症

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
Cerebral blood flow

研究概览

简要总结

The objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.

详细描述

The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. The present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion and normobaric hypoxia (N=12).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy nonsmoking male
  • Age 18-45 yrs

排除标准

  • 未提供

结局指标

主要结局

Cerebral blood flow

时间窗: 0, 9 hours

Cerebral oxygen metabolism

时间窗: 0, 9 hours

Plasma cytokine content

时间窗: 0, 4, 19, 12 hours

Lake Louise Score

时间窗: 0, 4, 9, 12 hours

ESQ-C

时间窗: 0, 4, 9, 12 hours

Endotoxemia Score

时间窗: 0, 4, 9, 12 hours

次要结局

  • Cerebral net flux(0, 9 hours)
  • Mean arterial pressure(Hourly, 0 through 12 hours)
  • Heart rate(Hourly, 0 through 12 hours)
  • Oxygen saturation(Hourly, 0 through 12 hours)
  • Body temperature(Hourly, 0 through 12 hours)

研究者

申办方类型
Other

研究点 (2)

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