Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects ((RAV))
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
研究概览
详细说明
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Linköping、瑞典
- Intensive Care Unit, University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy, without allergies and with the age 18 years or above
Exclusion Criteria:
- Heart failure
- Signs of kidney injury/failure
- Severe allergies
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Rapid - Slow
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (30 minutes), second time slow (120 minutes). Albumin solution |
Infusion rate and effects
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实验性的：Slow - Rapid
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (120 minutes), second time slow (30 minutes). Albumin solution |
Infusion rate and effects
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma volume
大体时间：6 hours
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Albumin infusion expands the plasma volume and dilutes hemoglobin.
The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
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6 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Colloid osmotic pressure
大体时间：6 hours
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Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma.
Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure.
This effect is measured.
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6 hours
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Fluid recruitment from tissues
大体时间：6 hours
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The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured.
The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.
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6 hours
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合作者和调查者
调查人员
- 首席研究员：Joachim Zdolsek, MD, PhD,Assoc prof、University Hospital, Linkoeping
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RAV
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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