NCT01686776已完成3 期
A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
Ake Norberg2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年9月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Transcapillary Escape Rate (TER)of Albumin
研究概览
简要总结
This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.
- Primary Objective:
- Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin?
- Secondary Objective:
- How do three different measures of albumin turnover correlate in volunteers?
- How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers (treatment arm I)
- •on contraceptive agent and/or contraceptive device
- •visual peripheral veins
- •signed informed consent
- •planned for elective larger interabdominal surgery (treatment arm II)
- •patients with a acute pancreatitis or cholecystitis (treatment arm III)
排除标准
- •pregnant women and/or lactating
- •allergy towards excipients in 123 I HSA or 125 I HSA
- •participates in another study involving radiation or stabile isotopes within a period of 60 days to study start
- •it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good
研究组 & 干预措施
123 I-HSA + 125 I-HSA
Active Comparator
Healthy Volunteers, N=16
干预措施: 123 I-HSA + 125 I HSA (Other)
123 I- HSA + 125 I-HSA
Experimental
Patients, planned for elective Major Abdominal Surgery, N=16
干预措施: 123 I-HSA + 125 I HSA (Other)
123-I-HSA+125 I-HSA
Experimental
Patients, with a acute pancreatitis or cholecystitis, N=16
干预措施: 123 I-HSA + 125 I HSA (Other)
结局指标
主要结局
Transcapillary Escape Rate (TER)of Albumin
时间窗: 42 days
Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?
次要结局
- Fractional catabolic rate (FCR)(42 days)
研究者
Ake Norberg
M.D, PhD
Karolinska Institutet
研究点 (2)
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