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

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ClinicalTrials.gov Identifier: NCT01686776
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ake Norberg, Karolinska Institutet

Brief 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?

Condition or disease Intervention/treatment Phase
Healthy SIRS Other: 123 I-HSA + 125 I HSA Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
Actual Study Start Date : September 27, 2012
Actual Primary Completion Date : June 1, 2013
Actual Study Completion Date : June 1, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Altretamine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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?



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686776


Locations
Sweden
Karolinska University Hospital, Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Ake Norberg
Investigators
Study Chair: Olav Rooyackers, PhDProfessor Karolinska University Hopsital

Publications of Results:
Responsible Party: Ake Norberg, M.D, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01686776     History of Changes
Other Study ID Numbers: 3.00 # amended version 1.1
2012-002638-35 ( EudraCT Number )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Keywords provided by Ake Norberg, Karolinska Institutet:
Plasma albumine
Plasma volume
Transcapillary escape rate
Inflammation
Circulation