Healthy, SIRS
Conditions
Keywords
Plasma albumine, Plasma volume, Transcapillary escape rate, Inflammation, Circulation
Brief 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?
Interventions
OTHER123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate
Sponsors
Ake Norberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
3 parallell Groups were measured regarding plasma volume and transcapillary escape rate of albumin where commercial 125I-iodinated human serum albumin was compared to hospital manufactured 123I- iodinated human serum albumin
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcapillary Escape Rate (TER)of Albumin | 42 days | Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional catabolic rate (FCR) | 42 days | Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| plasma albumin turnover rate | 42 days | How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups? |
Countries
Sweden
Outcome results
None listed