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A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA

Healthy Clinical Trial

Official title:
A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery

Clinical Trial Summary

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.

1. 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?

2. 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?

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01686776
Study type Interventional
Source Karolinska Institutet
Contact
Status Completed
Phase Phase 3
Start date September 27, 2012
Completion date June 1, 2013
View Details
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