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NCT Number: NCT01686776

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?

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Key information

Conditions

Healthy Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms SIRS

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska University Hospital, Huddinge

Stockholm, SE-141 86, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

123 I-HSA + 125 I HSA

Other

Compare and validate the method of measuring albumine turnover rate

Primary outcomes

  1. Transcapillary Escape Rate (TER)of Albumin

    Time frame: 42 days

    Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?

Secondary outcomes

  1. Fractional catabolic rate (FCR)

    Time frame: 42 days

    Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate

Other outcomes

  1. plasma albumin turnover rate

    Time frame: 42 days

    How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups?

Sponsors and collaborators

Lead sponsor

Ake Norberg

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 18, 2012
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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