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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Ake Norberg, Karolinska Institutet.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Ake Norberg, Karolinska Institutet Identifier:
First received: September 13, 2012
Last updated: January 16, 2013
Last verified: January 2013

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?

Condition Intervention Phase
Healthy SIRS Other: 123 I-HSA + 125 I HSA Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery

Resource links provided by NLM:

Further study details as provided by Ake Norberg, Karolinska Institutet:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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?

Estimated Enrollment: 48
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 123 I-HSA + 125 I-HSA
Healthy Volunteers, N=16
Other: 123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate
Experimental: 123 I- HSA + 125 I-HSA
Patients, planned for elective Major Abdominal Surgery, N=16
Other: 123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate
Experimental: 123-I-HSA+125 I-HSA
Patients, with a acute pancreatitis or cholecystitis, N=16
Other: 123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01686776

Contact: Åke Norbebrg, M.D PhD +46-8-58585159

Karolinska University Hospital, Huddinge Recruiting
Stockholm, Sweden, SE-141 86
Principal Investigator: Åke Norberg, M.D.,PhD.         
Sponsors and Collaborators
Ake Norberg
Study Chair: Olav Rooyackers, PhDProfessor Karolinska University Hopsital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ake Norberg, M.D, PhD, Karolinska Institutet Identifier: NCT01686776     History of Changes
Other Study ID Numbers: 3.00 # amended version 1.1
Study First Received: September 13, 2012
Last Updated: January 16, 2013

Keywords provided by Ake Norberg, Karolinska Institutet:
Plasma albumine
Plasma volume
Transcapillary escape rate
Circulation processed this record on August 21, 2017