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临床试验/NCT01049087
NCT01049087已完成不适用

Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

Zealand University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin

研究概览

简要总结

The purpose of the present study is to compare plasma volume determination by 99mTc-labeled albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that plasma volume determined by the different methods are the same.

详细描述

For many years, radioiodinated albumin has been "the golden standard" for measurement of plasma volume. There are a number of clinical situations in which a nuclide with a shorter half-life would be preferred. Furthermore, due to periodic lapses in the availability in the delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for plasma volume determination.

99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high labeling efficiency and short half-life.

In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume is estimated from multiple postinjection samples for accurate zero-time extrapolation in order to correct for leakage of labeled albumin from the vascular compartment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 27 kg/m2
  • Written informed consent

排除标准

  • Hypertension (140/90 mmHg)
  • Diabetes mellitus
  • Any use of medication
  • Pregnancy

结局指标

主要结局

Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin

时间窗: January 2011

次要结局

  • Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation(January 2011)

研究者

申办方类型
Other

研究点 (2)

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