<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/NCT01679249</url>
  </required_header>
  <id_info>
    <org_study_id>01249</org_study_id>
    <nct_id>NCT01679249</nct_id>
  </id_info>
  <brief_title>Blood Volume Analysis and Related Outcomes in Hemodialysis</brief_title>
  <official_title>Blood Volume Analysis and Related Outcomes in Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA New York Harbor Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daxor Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>VA New York Harbor Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration&#xD;
      (UF) is essential for determining the efficacy of HD, as well as for reducing complications&#xD;
      related to hypovolemia or, conversely, chronic volume overload.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Accurate assessment of the BV and distribution of body fluids is essential for&#xD;
      prescribing HD and for reducing complications related to hypovolemia and volume overload.&#xD;
      Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method,&#xD;
      cannot be used to determine the absolute levels of BV. Here we report the first study of&#xD;
      isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator&#xD;
      dilutional method.&#xD;
&#xD;
      10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM&#xD;
      before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV&#xD;
      with an accuracy of ±2.5%, by using &lt;25μCi of iodinated I-131 albumin. It assumes normal BV&#xD;
      for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss&#xD;
      from the extravascular component of the extracellular space (EV) was calculated by&#xD;
      subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were&#xD;
      measured by CLM-III during the same HD session. Bland-Altman plot was used to compare&#xD;
      relative BV change pre- and post-HD by IBVM and CLM-III.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood volume measurement and comparison to Crit-Line reading</measure>
    <time_frame>Six months</time_frame>
    <description>To compare the results obtained by two different methods of assessing BV: direct measurement of BV using the Blood Volume Analyzer (BVA-100) vs. indirect measurement of relative changes in BV using the Crit-Line Monitor (CLM III). Blood volume is measured in liters and compared with &quot;ideal blood volume&quot; nomograms. Crit-Line Monitor measures relative change in blood volume as a percentage change and does not have absolute values.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>End Stage Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Hemodialysis patients</arm_group_label>
    <description>Stable prevalent patients on 3-times-per-week hemodialysis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the pool of patients at the Dialysis Center at the&#xD;
        Department of Veteran Affairs New York Harbor Healthcare System who are currently&#xD;
        undergoing dialysis for treatment of chronic kidney disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;21 years&#xD;
&#xD;
          -  Primary diagnosis of either chronic or acute kidney disease&#xD;
&#xD;
          -  Currently receiving HD treatment&#xD;
&#xD;
          -  Thrice-weekly or twice-weekly HD schedule&#xD;
&#xD;
          -  Treated with standard bicarbonate HD for at least the preceding 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women or nursing mothers&#xD;
&#xD;
          -  Known hypersensitivity to iodine, eggs, albumin or any other component of the Volumex&#xD;
             injection kit&#xD;
&#xD;
          -  Current enrollment in another investigational treatment protocol for dialysis&#xD;
&#xD;
          -  The need to perform hemodialysis with predilution because this will interfere with&#xD;
             measurements of relative blood volume changes (ΔRBV)&#xD;
&#xD;
          -  Kidney transplantation&#xD;
&#xD;
          -  Malignancy requiring chemotherapy&#xD;
&#xD;
          -  Unmeasurable blood pressure with a sphygmomanometer&#xD;
&#xD;
          -  Active hematological disease&#xD;
&#xD;
          -  Active gastrointestinal bleeding&#xD;
&#xD;
          -  Severe malnutrition (predialysis serum albumin &lt;2.6 g/dL)&#xD;
&#xD;
          -  Persistent condition of intradialytic blood pressure instability (hypotensive episodes&#xD;
             in &gt;80% of regular dialysis sessions) within the previous one month period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David S Goldfarb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA New York Harbor Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Harbor VA Healthcare System Hemodialysis Unit</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA New York Harbor Healthcare System</investigator_affiliation>
    <investigator_full_name>David S. Goldfarb, M.D.</investigator_full_name>
    <investigator_title>Chief, Nephrology</investigator_title>
  </responsible_party>
  <keyword>extracellular fluid volume</keyword>
  <keyword>hypotension</keyword>
  <keyword>hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679249
org study id: 01249
nct id: NCT01679249
lead sponsor: 
collaborator: 
has dmc: No
An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration
      (UF) is essential for determining the efficacy of HD, as well as for reducing complications
      related to hypovolemia or, conversely, chronic volume overload.
Background: Accurate assessment of the BV and distribution of body fluids is essential for
      prescribing HD and for reducing complications related to hypovolemia and volume overload.
      Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method,
      cannot be used to determine the absolute levels of BV. Here we report the first study of
      isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator
      dilutional method.

      10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM
      before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV
      with an accuracy of ±2.5%, by using <25μCi of iodinated I-131 albumin. It assumes normal BV
      for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss
      from the extravascular component of the extracellular space (EV) was calculated by
      subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were
      measured by CLM-III during the same HD session. Bland-Altman plot was used to compare
      relative BV change pre- and post-HD by IBVM and CLM-III.
observational model: Case-Only
time perspective: Prospective
measure: Blood volume measurement and comparison to Crit-Line reading
time frame: Six months
description: To compare the results obtained by two different methods of assessing BV: direct measurement of BV using the Blood Volume Analyzer (BVA-100) vs. indirect measurement of relative changes in BV using the Crit-Line Monitor (CLM III). Blood volume is measured in liters and compared with "ideal blood volume" nomograms. Crit-Line Monitor measures relative change in blood volume as a percentage change and does not have absolute values.
arm group label: Hemodialysis patients
description: Stable prevalent patients on 3-times-per-week hemodialysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: David S Goldfarb, MD
role: Principal Investigator
affiliation: VA New York Harbor Healthcare System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA New York Harbor Healthcare System
investigator full name: David S. Goldfarb, M.D.
investigator title: Chief, Nephrology
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic