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