<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01686776</url>
  </required_header>
  <id_info>
    <org_study_id>3.00 # amended version 1.1</org_study_id>
    <secondary_id>2012-002638-35</secondary_id>
    <nct_id>NCT01686776</nct_id>
  </id_info>
  <brief_title>A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA</brief_title>
  <official_title>A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ake Norberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, validation study of a extempore made tracer compared with a&#xD;
      commercial. Studies with tracer have no medical effects but are used for studying human&#xD;
      physiology, in this case pharmacokinetic variables of endogenous albumin distribution and&#xD;
      turnover at different levels of inflammation.&#xD;
&#xD;
        1. Primary Objective:&#xD;
&#xD;
           - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured&#xD;
           SERALB-125 give identical values of calculated blood plasma volume and capillary leakage&#xD;
           measured as transcapillary escape rate of albumin?&#xD;
&#xD;
        2. Secondary Objective:&#xD;
&#xD;
             -  How do three different measures of albumin turnover correlate in volunteers?&#xD;
&#xD;
             -  How do the pharmacokinetic parameters of endogenous albumin vary between the three&#xD;
                study groups?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2012</start_date>
  <completion_date type="Actual">June 1, 2013</completion_date>
  <primary_completion_date type="Actual">June 1, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transcapillary Escape Rate (TER)of Albumin</measure>
    <time_frame>42 days</time_frame>
    <description>Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fractional catabolic rate (FCR)</measure>
    <time_frame>42 days</time_frame>
    <description>Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>plasma albumin turnover rate</measure>
    <time_frame>42 days</time_frame>
    <description>How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups?</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <condition>SIRS</condition>
  <arm_group>
    <arm_group_label>123 I-HSA + 125 I-HSA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy Volunteers, N=16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>123 I- HSA + 125 I-HSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients, planned for elective Major Abdominal Surgery, N=16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>123-I-HSA+125 I-HSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients, with a acute pancreatitis or cholecystitis, N=16</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>123 I-HSA + 125 I HSA</intervention_name>
    <description>Compare and validate the method of measuring albumine turnover rate</description>
    <arm_group_label>123 I- HSA + 125 I-HSA</arm_group_label>
    <arm_group_label>123 I-HSA + 125 I-HSA</arm_group_label>
    <arm_group_label>123-I-HSA+125 I-HSA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers (treatment arm I)&#xD;
&#xD;
          -  on contraceptive agent and/or contraceptive device&#xD;
&#xD;
          -  visual peripheral veins&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  planned for elective larger interabdominal surgery (treatment arm II)&#xD;
&#xD;
          -  patients with a acute pancreatitis or cholecystitis (treatment arm III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women and/or lactating&#xD;
&#xD;
          -  allergy towards excipients in 123 I HSA or 125 I HSA&#xD;
&#xD;
          -  participates in another study involving radiation or stabile isotopes within a period&#xD;
             of 60 days to study start&#xD;
&#xD;
          -  it is the opinion of the principle investigator that the patient/subject should not&#xD;
             participate for his/hers own good&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olav Rooyackers, PhDProfessor</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska University Hopsital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital, Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Komaromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg A. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. doi: 10.1186/s13054-016-1536-6.</citation>
    <PMID>27846908</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Ake Norberg</investigator_full_name>
    <investigator_title>M.D, PhD</investigator_title>
  </responsible_party>
  <keyword>Plasma albumine</keyword>
  <keyword>Plasma volume</keyword>
  <keyword>Transcapillary escape rate</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Circulation</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686776
org study id: 3.00 # amended version 1.1
secondary id: 2012-002638-35
nct id: NCT01686776
lead sponsor: 
has dmc: Yes
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?
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
primary purpose: Other
masking: None (Open Label)
measure: Transcapillary Escape Rate (TER)of Albumin
time frame: 42 days
description: Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?
measure: Fractional catabolic rate (FCR)
time frame: 42 days
description: Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate
measure: plasma albumin turnover rate
time frame: 42 days
description: How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups?
arm group label: 123 I-HSA + 125 I-HSA
arm group type: Active Comparator
description: Healthy Volunteers, N=16
arm group label: 123 I- HSA + 125 I-HSA
arm group type: Experimental
description: Patients, planned for elective Major Abdominal Surgery, N=16
arm group label: 123-I-HSA+125 I-HSA
arm group type: Experimental
description: Patients, with a acute pancreatitis or cholecystitis, N=16
intervention type: Other
intervention name: 123 I-HSA + 125 I HSA
description: Compare and validate the method of measuring albumine turnover rate
arm group label: 123 I- HSA + 125 I-HSA
arm group label: 123 I-HSA + 125 I-HSA
arm group label: 123-I-HSA+125 I-HSA
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Olav Rooyackers, PhDProfessor
role: Study Chair
affiliation: Karolinska University Hopsital
facility: 
country: Sweden
citation: Komaromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg A. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. doi: 10.1186/s13054-016-1536-6.
PMID: 27846908
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Ake Norberg
investigator title: M.D, PhD