<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/NCT02212327</url>
  </required_header>
  <id_info>
    <org_study_id>140157</org_study_id>
    <nct_id>NCT02212327</nct_id>
  </id_info>
  <brief_title>Testing Tissue Sodium Stores in CAPD Patients-Aims 1 &amp; 2</brief_title>
  <official_title>Testing Tissue Sodium Stores in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients Receiving Icodextrin or Glucose-Based Dialysate, A Randomized Trial-Aims 1 &amp; 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators' overarching goal is to improve long-term outcomes for end stage renal&#xD;
      disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal&#xD;
      dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure,&#xD;
      nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally&#xD;
      regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD&#xD;
      patients the peritoneal membrane, must serve that purpose. Determining volume status in PD&#xD;
      patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators&#xD;
      have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic&#xD;
      resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our&#xD;
      technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this&#xD;
      novel technique to PD patients.&#xD;
&#xD;
      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using&#xD;
      Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance&#xD;
      measurements and cross-sectional clinical data.&#xD;
&#xD;
      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are&#xD;
      increased in PD patients with volume expansion and in those patients with high soluble&#xD;
      vascular endothelial growth factor receptor-3 (sFlt-4) levels.&#xD;
&#xD;
      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal&#xD;
      function in PD patients.&#xD;
&#xD;
      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was&#xD;
      found to have no utility in predicting preservation of residual renal function in PD&#xD;
      patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will&#xD;
      fulfill that function and will be inversely, rather than directly, related.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 29, 2016</completion_date>
  <primary_completion_date type="Actual">November 29, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Aim 1: Na+ stores in PD subjects vs. controls</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Aim 2: a change in Na+ stores in PD subjects</measure>
    <time_frame>baseline and 2 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>PD subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood and urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients on PD and healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Both subject groups:&#xD;
&#xD;
          -  Age 18 to 80 years;&#xD;
&#xD;
          -  BMI &lt; 40;&#xD;
&#xD;
          -  Ability to give informed consent;&#xD;
&#xD;
          -  Life expectancy greater than 6 months.&#xD;
&#xD;
        PD subjects:&#xD;
&#xD;
          -  On peritoneal dialysis for greater than 3 months;&#xD;
&#xD;
          -  Using glucose lactate-buffered PD solutions with consistent glucose exposure;&#xD;
&#xD;
          -  Stable peritoneal prescription (Kt/V &gt; 1.7 or Tccr &gt; 50 ml/week/1.73 m2).&#xD;
&#xD;
        Control subjects:&#xD;
&#xD;
          -  Estimated glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2;&#xD;
&#xD;
          -  No proteinuria.&#xD;
&#xD;
        Exclusion Criteria (both subject groups):&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Intolerance to study protocols;&#xD;
&#xD;
          -  Severe, unstable, active, or chronic inflammatory disease (congestive heart failure-NY&#xD;
             Class IV, active infection, active connective tissue disorder, active cancer or cancer&#xD;
             history in the prior 5 years, HIV, liver disease, including active chronic hepatitis B&#xD;
             or C);&#xD;
&#xD;
          -  Active inflammatory conditions [systemic lupus erythematosus (SLE), rheumatoid&#xD;
             arthritis (RA), minimal change disease (MCD)];&#xD;
&#xD;
          -  Patients prescribed or being treated with spironolactone;&#xD;
&#xD;
          -  History of cirrhosis;&#xD;
&#xD;
          -  Poor compliance with dialysis prescription.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alp Ikizler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jens Titze, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Alp Ikizler</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Na+ MRI</keyword>
  <keyword>salt stores</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02212327
org study id: 140157
nct id: NCT02212327
lead sponsor: 
collaborator: 
has dmc: No
The investigators' overarching goal is to improve long-term outcomes for end stage renal
      disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal
      dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure,
      nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally
      regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD
      patients the peritoneal membrane, must serve that purpose. Determining volume status in PD
      patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators
      have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic
      resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our
      technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this
      novel technique to PD patients.

      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using
      Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance
      measurements and cross-sectional clinical data.

      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are
      increased in PD patients with volume expansion and in those patients with high soluble
      vascular endothelial growth factor receptor-3 (sFlt-4) levels.

      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal
      function in PD patients.

      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was
      found to have no utility in predicting preservation of residual renal function in PD
      patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will
      fulfill that function and will be inversely, rather than directly, related.
observational model: Case-Control
time perspective: Prospective
measure: Aim 1: Na+ stores in PD subjects vs. controls
time frame: baseline
measure: Aim 2: a change in Na+ stores in PD subjects
time frame: baseline and 2 years
arm group label: PD subjects
arm group label: Controls
blood and urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alp Ikizler, MD
role: Principal Investigator
affiliation: Vanderbilt University
last name: Jens Titze, MD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Alp Ikizler
investigator title: Professor
mesh term: Kidney Failure, Chronic