NCT01062776已完成1 期
New Method to Detect Dehydration
Sodertalje Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- As determined by volume kinetics, a healthy human male eliminates infused crystalloid fluid more slowly when being in the dehydrated state as compared to when being normohydrated.
研究概览
简要总结
- The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration.
- The hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects.
- We induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.
详细描述
- Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of water at 6:00 AM to make sure they are not dehydrated when the experiments begin.
- On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (Masimo´s Radical 7).
- On two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected and the volume measured.
- The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.
- The accuracy and precision of the non-invasive monitoring of Hgb can be determined.
- The study is ended with that the Hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water.
- Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male.
排除标准
- •Disease for which daily medication is required.
- •Poor peripheral perfusion; defined as a perfusion index, as measured by Masimo´s Radical 7, of 2 or less.
结局指标
主要结局
As determined by volume kinetics, a healthy human male eliminates infused crystalloid fluid more slowly when being in the dehydrated state as compared to when being normohydrated.
时间窗: December 2010
次要结局
- The volume kinetics of an infusion fluid can/can not be measured as accurately by non-invasive monitoring as by invasive monitoring of the blood hemoglobin concentration(May 2010 (preliminary analysis))
研究者
研究点 (2)
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