<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/NCT03303391</url>
  </required_header>
  <id_info>
    <org_study_id>STU 032017-024</org_study_id>
    <nct_id>NCT03303391</nct_id>
  </id_info>
  <brief_title>Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration</brief_title>
  <acronym>IBPS</acronym>
  <official_title>Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an open label randomized clinical trial that comparing intradialytic blood&#xD;
      pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid&#xD;
      management of maintenance hemodialysis patients. It also includes a cross sectional component&#xD;
      evaluating the associations between intradialytic blood pressure slopes ascertained over 2&#xD;
      week periods with measurements of extracellular water/body weight obtained with&#xD;
      multifrequency bioimpedance spectroscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding Expired&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mean Ambulatory Systolic Blood Pressure</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Extracellular Volume/Body Weight Ratio</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>ESRD</condition>
  <condition>Extracellular Fluid Alteration</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBPS Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intradialytic Blood Pressure Slope Based Ultrafiltration</intervention_name>
    <description>Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
    <arm_group_label>IBPS Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  End Stage Renal Disease on Maintenance Hemodialysis&#xD;
&#xD;
          -  Hypertension defined as systolic blood pressure &gt; 140 mmHg pre-dialysis or &gt;130 mmHg&#xD;
             post dialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodialysis Vintage &lt; 1 month&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Nadir Systolic Blood Pressure &lt; 95 mmHg&#xD;
&#xD;
          -  Pre or Post dialysis systolic blood pressure &gt; 180 mmHg&#xD;
&#xD;
          -  Decrease in systolic blood pressure &gt;60 mmHg from pre to post dialysis&#xD;
&#xD;
          -  Ultrafiltration rate &gt;13 mL/kg/hr&#xD;
&#xD;
          -  Peridialytic Midodrine Use&#xD;
&#xD;
          -  Intradialytic Clonidine use&#xD;
&#xD;
          -  Documented Antihypertensive Medication Non-adherence&#xD;
&#xD;
        Bioimpedance will not be peformed on patients with&#xD;
&#xD;
          -  amputated arms or legs&#xD;
&#xD;
          -  cardiac defibrillator or pacemaker&#xD;
&#xD;
          -  presence of metal prostheses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Van Buren, MD, MSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Davita Dialysis</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>December 21, 2021</results_first_submitted>
  <results_first_submitted_qc>March 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2022</results_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Peter Van Buren</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03303391/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
        </group>
        <group group_id="P2">
          <title>IBPS Group</title>
          <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.&#xD;
Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
        </group>
        <group group_id="B2">
          <title>IBPS Group</title>
          <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.&#xD;
Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>2 intervention subjects withdrew prior to study intervention starting</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.4" spread="11"/>
                    <measurement group_id="B2" value="57.3" spread="13"/>
                    <measurement group_id="B3" value="54.6" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <population>Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Mean Ambulatory Systolic Blood Pressure</title>
        <description>The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)</description>
        <time_frame>Baseline, 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
          </group>
          <group group_id="O2">
            <title>IBPS Group</title>
            <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.&#xD;
Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Ambulatory Systolic Blood Pressure</title>
          <description>The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="12"/>
                    <measurement group_id="O2" value="-21.3" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Extracellular Volume/Body Weight Ratio</title>
        <description>expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month</description>
        <time_frame>Baseline, 4 months</time_frame>
        <population>In the Standard of Care arm/ group, it was not possible to obtain these measurements in 3 subjects (amputations, defibrillators, implanted metal) and are missing the data since they were unable to undergo these measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
          </group>
          <group group_id="O2">
            <title>IBPS Group</title>
            <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.&#xD;
Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Extracellular Volume/Body Weight Ratio</title>
          <description>expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month</description>
          <population>In the Standard of Care arm/ group, it was not possible to obtain these measurements in 3 subjects (amputations, defibrillators, implanted metal) and are missing the data since they were unable to undergo these measurements.</population>
          <units>L/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.003" spread=".02"/>
                    <measurement group_id="O2" value="-.01" spread=".007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were determined over a 4 month period per subject</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist</description>
        </group>
        <group group_id="E2">
          <title>IBPS Group</title>
          <description>This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.&#xD;
Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>Patient interaction</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Intradialytic Hypotension</sub_title>
                <description>At least one episode of systolic blood pressure &lt;90 mmHg</description>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" events="11" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Peter Van Buren</name_or_title>
      <organization>University of Texas Southwestern Medical Center</organization>
      <phone>214-645-8293</phone>
      <email>peter.vanburen@utsouthwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03303391
org study id: STU 032017-024
nct id: NCT03303391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is an open label randomized clinical trial that comparing intradialytic blood
      pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid
      management of maintenance hemodialysis patients. It also includes a cross sectional component
      evaluating the associations between intradialytic blood pressure slopes ascertained over 2
      week periods with measurements of extracellular water/body weight obtained with
      multifrequency bioimpedance spectroscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Mean Ambulatory Systolic Blood Pressure
time frame: Baseline, 4 months
description: The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
measure: Change in Extracellular Volume/Body Weight Ratio
time frame: Baseline, 4 months
description: expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month
arm group label: Standard Care
arm group type: No Intervention
description: This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
arm group label: IBPS Group
arm group type: Experimental
description: This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.
intervention type: Other
intervention name: Intradialytic Blood Pressure Slope Based Ultrafiltration
description: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments
arm group label: IBPS Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Peter Van Buren, MD, MSCS
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Peter Van Buren
investigator title: Assistant Professor
mesh term: Hypertension
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 