NCT01686776

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ake Norberg · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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?

Conditions

• Healthy
• SIRS

Interventions

Type	Name	Description
OTHER	123 I-HSA + 125 I HSA	Compare and validate the method of measuring albumine turnover rate

Timeline

• Start date: 2012-09-27
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-09-18
• Last updated: 2018-02-19

Locations

1 site across 1 country: Sweden