Healthy Clinical Trial
Official title:
A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
Verified date | February 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 30 |
Est. completion date | June 1, 2013 |
Est. primary completion date | June 1, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital, Huddinge | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Ake Norberg |
Sweden,
Komáromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg Å. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | plasma albumin turnover rate | How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups? | 42 days | |
Primary | 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 | 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 |
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