<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/NCT03280901</url>
  </required_header>
  <id_info>
    <org_study_id>HD-Remodel-UK-01</org_study_id>
    <secondary_id>IRAS 207142</secondary_id>
    <nct_id>NCT03280901</nct_id>
  </id_info>
  <brief_title>HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning</brief_title>
  <acronym>HD-REMODEL</acronym>
  <official_title>HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Medical Care Deutschland GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Medical Care Deutschland GmbH</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>
      The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,&#xD;
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.&#xD;
      The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be&#xD;
      compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if&#xD;
      thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress&#xD;
      when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius)&#xD;
      offers a way to overcome this to regulate thermal balance during dialysis and achieve a&#xD;
      neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters&#xD;
      will be standardised between treatment arms using blood volume monitoring (BVM) and clinical&#xD;
      assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,&#xD;
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.&#xD;
      The Primary objectives are to investigate the difference in cardiac perfusion, structure and&#xD;
      function between standard HD and thermocontrolled HD using magnetic imaging techniques, to&#xD;
      observe the the changes in renal perfusion and oxygenation within one dialysis session and&#xD;
      the changes to cerebral perfusion within one dialysis session.&#xD;
&#xD;
      The secondary objectives are to investigate the difference in cerebral perfusion, structure,&#xD;
      oedema and function between standard HD and thermocontrolled HD, the difference in renal&#xD;
      perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in&#xD;
      visual acuity and cognitive assessment across a dialysis session and over a dialysis&#xD;
      treatment course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>monocentric, block randomized, open, crossover study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cardiac output during standard HD and thermocontrolled HD</measure>
    <time_frame>after 2 and 4 weeks after randomisation</time_frame>
    <description>Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in renal perfusion during standard HD and thermocontrolled HD</measure>
    <time_frame>after 2 and 4 weeks after randomisation</time_frame>
    <description>Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cerebral perfusion during standard HD and thermocontrolled HD</measure>
    <time_frame>after 2 and 4 weeks after randomisation</time_frame>
    <description>Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Renal Failure</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Congenital Disorders</condition>
  <arm_group>
    <arm_group_label>Standard HD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thermocontrolled HD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HD, Magnetic Resonance Imaging (MRI) scans</intervention_name>
    <description>HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions</description>
    <arm_group_label>Standard HD</arm_group_label>
    <arm_group_label>Thermocontrolled HD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Change in dry weight (clinically defined) in 4 weeks prior to recruitment&#xD;
&#xD;
          -  Dialysate composition other than: sodium≥137mmol/L, potassium≥2.0mmol/L,&#xD;
             calcium≥1.5mmol/L, magnesium≥0.5mmol/L, glucose 1.0g/L&#xD;
&#xD;
          -  Instability on dialysis in 4 weeks prior to recruitment leading to either:&#xD;
&#xD;
               -  Emergency medical attention&#xD;
&#xD;
               -  Infusion of additional fluid&#xD;
&#xD;
               -  Loss in consciousness&#xD;
&#xD;
               -  Arrhythmia&#xD;
&#xD;
               -  Chest pain&#xD;
&#xD;
               -  Or any other medical condition that precludes the scan session in opinion of the&#xD;
                  investigator&#xD;
&#xD;
          -  Dialysed via a synthetic line, central venous catheter or graft&#xD;
&#xD;
          -  Qa &lt; 500ml/min&#xD;
&#xD;
          -  NYHA Stage IV heart failure (New York Heart Association)&#xD;
&#xD;
          -  Active infection or malignancy&#xD;
&#xD;
          -  Contraindication to MRI scanning including claustrophobia, pacemaker, metallic&#xD;
             implants etc&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or&#xD;
             planning pregnancy or lactation period&#xD;
&#xD;
          -  Medical conditions or overall physical frailty precludes scan session in opinion of&#xD;
             investigator&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#xD;
&#xD;
          -  Any condition which could interfere with the patient's ability to comply with the&#xD;
             study&#xD;
&#xD;
          -  Participation in an interventional clinical study during the preceding 30 days&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80, male and female&#xD;
&#xD;
          -  Informed consent signed and dated by study patient and investigator/authorised&#xD;
             physician&#xD;
&#xD;
          -  Average (4 weeks prior to recruitment) Ultrafiltration volumes ≥ 0.5 litres/ dialysis&#xD;
             session&#xD;
&#xD;
          -  Receiving dialysis via an arteriovenous fistula&#xD;
&#xD;
          -  Must be able to follow simple instruction in English (on safety grounds for MRI scans)&#xD;
             and be able to understand the nature and requirements of the study&#xD;
&#xD;
          -  Stable dialysis prescription&#xD;
&#xD;
          -  CKD5 (Chronic kidney disease) patients having renal replacement therapy with&#xD;
             haemodialysis/ haemodiafiltration (&gt;90 days)&#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>Maarten Taal, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas Selby, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal replacement therapy</keyword>
  <keyword>haemodialysis</keyword>
  <keyword>haemodiafiltration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03280901
org study id: HD-Remodel-UK-01
secondary id: IRAS 207142
nct id: NCT03280901
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
      The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be
      compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if
      thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress
      when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius)
      offers a way to overcome this to regulate thermal balance during dialysis and achieve a
      neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters
      will be standardised between treatment arms using blood volume monitoring (BVM) and clinical
      assessments.
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
      The Primary objectives are to investigate the difference in cardiac perfusion, structure and
      function between standard HD and thermocontrolled HD using magnetic imaging techniques, to
      observe the the changes in renal perfusion and oxygenation within one dialysis session and
      the changes to cerebral perfusion within one dialysis session.

      The secondary objectives are to investigate the difference in cerebral perfusion, structure,
      oedema and function between standard HD and thermocontrolled HD, the difference in renal
      perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in
      visual acuity and cognitive assessment across a dialysis session and over a dialysis
      treatment course.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: monocentric, block randomized, open, crossover study
primary purpose: Treatment
masking: None (Open Label)
measure: Change in cardiac output during standard HD and thermocontrolled HD
time frame: after 2 and 4 weeks after randomisation
description: Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI)
measure: Change in renal perfusion during standard HD and thermocontrolled HD
time frame: after 2 and 4 weeks after randomisation
description: Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI
measure: Change in cerebral perfusion during standard HD and thermocontrolled HD
time frame: after 2 and 4 weeks after randomisation
description: Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL
arm group label: Standard HD
arm group type: Experimental
description: HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions
arm group label: Thermocontrolled HD
arm group type: Experimental
description: HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions
intervention type: Other
intervention name: HD, Magnetic Resonance Imaging (MRI) scans
description: HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
arm group label: Standard HD
arm group label: Thermocontrolled HD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Maarten Taal, Professor
role: Study Chair
affiliation: University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
last name: Nicolas Selby, Dr
role: Principal Investigator
affiliation: University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No