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

This study is currently recruiting participants.
Verified January 2013 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Ake Norberg, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01686776
First received: September 13, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Transcapillary Escape Rate (TER)of Albumin [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686776

Contacts
Contact: Åke Norbebrg, M.D PhD +46-8-58585159 ake.norberg@karolinska.se

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

No publications provided

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
Study First Received: September 13, 2012
Last Updated: January 16, 2013
Health Authority: Sweden: Medical Products Agency.Amend approved#:151:2012/87317

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013