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

Study Overview
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Brief Summary
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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. 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? 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?

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

Conditions
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Healthy, SIRS

Intervention / Treatment
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* Other: 123 I-HSA + 125 I HSA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 123 I-HSA + 125 I-HSA<br>Healthy Volunteers, N=16 | Other: 123 I-HSA + 125 I HSA<br>* Compare and validate the method of measuring albumine turnover rate<br>|
| Experimental: 123 I- HSA + 125 I-HSA<br>Patients, planned for elective Major Abdominal Surgery, N=16 | Other: 123 I-HSA + 125 I HSA<br>* Compare and validate the method of measuring albumine turnover rate<br>|
| Experimental: 123-I-HSA+125 I-HSA<br>Patients, with a acute pancreatitis or cholecystitis, N=16 | Other: 123 I-HSA + 125 I HSA<br>* Compare and validate the method of measuring albumine turnover rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcapillary Escape Rate (TER)of Albumin | Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)? | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional catabolic rate (FCR) | Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma albumine, Plasma volume, Transcapillary escape rate, Inflammation, Circulation