<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/NCT04428372</url>
  </required_header>
  <id_info>
    <org_study_id>2019P003681</org_study_id>
    <nct_id>NCT04428372</nct_id>
  </id_info>
  <brief_title>MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)</brief_title>
  <official_title>MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal will measure the effects of mannitol administration versus placebo in&#xD;
      hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in&#xD;
      patient symptoms and blood pressure stability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants&#xD;
      will be performed over a 4-week period to determine the effect on:&#xD;
&#xD;
        -  Patient symptoms&#xD;
&#xD;
        -  The magnitude of intra-dialytic hypotension&#xD;
&#xD;
      The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer&#xD;
      adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 6, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of average patient symptom score during mannitol arm using dialysis symptom index compared with the average score during the placebo arm (scale 0-150; higher scores worse)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of average patient symptom score during mannitol arm using modified Edmonton symptom assessment system compared with the average score during the placebo arm (scale 0-100; higher scores worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of average patient symptom score during mannitol arm using SMAART HD questionnaire compared with the average score during the placebo arm (scale 0-60 on 12-questions, higher scores worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-dialytic hypotension</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hemodialysis Complication</condition>
  <condition>Hemodynamic Instability</condition>
  <arm_group>
    <arm_group_label>Mannitol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mannitol</intervention_name>
    <description>Hypertonic mannitol infusion</description>
    <arm_group_label>Mannitol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% saline</intervention_name>
    <description>Normal saline 'placebo' arm</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maintenance HD (&gt;90 days)&#xD;
&#xD;
          -  Age ≥18y&#xD;
&#xD;
          -  Thrice-weekly HD&#xD;
&#xD;
          -  IDH-prone (defined as nadir intra-dialytic SBP &lt;100 mmHg in ≥30% of sessions in the&#xD;
             prior 4 weeks)&#xD;
&#xD;
          -  Hematocrit&gt;21%&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction or stroke within one month&#xD;
&#xD;
          -  Pre-HD serum potassium &gt;6.5 mmol/L in last 4 weeks&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Institutionalized individuals&#xD;
&#xD;
          -  Life expectancy &lt;2 months&#xD;
&#xD;
          -  Planned renal transplant within 2 months&#xD;
&#xD;
          -  Active enrollment in another interventional trial&#xD;
&#xD;
          -  Known allergy to mannitol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Finnian R Mc Causland, MBBCH, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Finnian R Mc Causland, MBBCh, MMSc</last_name>
    <phone>617-732-6432</phone>
    <email>fmccausland@bwh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brigham and Women's</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Finnian Mc Causland</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Finnian McCausland</investigator_full_name>
    <investigator_title>Associate Physician</investigator_title>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Modest sized single-center study with no plan to share individual participant data</ipd_description>
  </patient_data>
  <!-- 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/NCT04428372
org study id: 2019P003681
nct id: NCT04428372
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This proposal will measure the effects of mannitol administration versus placebo in
      hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in
      patient symptoms and blood pressure stability.
A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants
      will be performed over a 4-week period to determine the effect on:

        -  Patient symptoms

        -  The magnitude of intra-dialytic hypotension

      The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer
      adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Patient Symptoms
time frame: 4 weeks
description: Comparison of average patient symptom score during mannitol arm using dialysis symptom index compared with the average score during the placebo arm (scale 0-150; higher scores worse)
measure: Patient Symptoms
time frame: 4 weeks
description: Comparison of average patient symptom score during mannitol arm using modified Edmonton symptom assessment system compared with the average score during the placebo arm (scale 0-100; higher scores worse)
measure: Patient Symptoms
time frame: 4 weeks
description: Comparison of average patient symptom score during mannitol arm using SMAART HD questionnaire compared with the average score during the placebo arm (scale 0-60 on 12-questions, higher scores worse)
measure: Intra-dialytic hypotension
time frame: 4 weeks
description: Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm
arm group label: Mannitol
arm group type: Experimental
description: intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis
arm group label: Placebo
arm group type: Placebo Comparator
description: 0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis
intervention type: Drug
intervention name: Mannitol
description: Hypertonic mannitol infusion
arm group label: Mannitol
intervention type: Drug
intervention name: 0.9% saline
description: Normal saline 'placebo' arm
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Finnian R Mc Causland, MBBCH, MMSc
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Finnian R Mc Causland, MBBCh, MMSc
phone: 617-732-6432
email: fmccausland@bwh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Finnian McCausland
investigator title: Associate Physician
mesh term: Mannitol
sharing ipd: No
ipd description: Modest sized single-center study with no plan to share individual participant data