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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01686776
Other study ID # 3.00 # amended version 1.1
Secondary ID 2012-002638-35
Status Completed
Phase Phase 3
First received September 13, 2012
Last updated February 15, 2018
Start date September 27, 2012
Est. completion date June 1, 2013

Study information

Verified date February 2018
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate

Locations

Country Name City State
Sweden Karolinska University Hospital, Huddinge Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Ake Norberg

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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

Outcome

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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