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

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?

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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