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

February 15, 2018 updated by: Ake Norberg

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)?
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
42 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ake Norberg

Investigators

  • Study Chair: Olav Rooyackers, PhDProfessor, Karolinska University Hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (ESTIMATE)

September 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3.00 # amended version 1.1
  • 2012-002638-35 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on 123 I-HSA + 125 I HSA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe