xml: <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/NCT05974436</url>
    </required_header>
    <id_info>
      <org_study_id>ONZ-2023-0170</org_study_id>
      <nct_id>NCT05974436</nct_id>
    </id_info>
    <brief_title>Green Dialysis: Dialysis With Reduced Dialysate Flow</brief_title>
    <official_title>Green Dialysis: Hemodialysis With Reduced Dialysate Flow</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Ghent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Ghent</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>
        Hemodialysis patients consume per year 18.720-26.208L of dialysis fluid (i.e. water). From an&#xD;
        ecological point of view, the present study investigated whether reducing this water amount&#xD;
        has an impact on the extraction and total solute removal of different uremic toxins. The&#xD;
        efficiency of hemodiafiltration with a standard high-flux dialyzer is compared to&#xD;
        hemodialysis with a medium cut-off dialyzer with a dialysate flow of either 700mL/min or&#xD;
        300mL/min.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemodialysis is currently performed with dialysate flows in the range 500 and 700mL/min&#xD;
        respectively in hemodialysis and hemodiafiltration mode. With a standard daytime dialysis&#xD;
        scheme of three times four hours a week, each patient consumes up to 360-504L dialysate per&#xD;
        week or 18.720-26.208L per year.&#xD;
  &#xD;
        From an ecological point of view, one can wonder whether patients can be dialyzed adequately&#xD;
        enough using hemodialysis mode with a lower dialysate flow, and as such consuming less water.&#xD;
  &#xD;
        Changing the mode from hemodiafiltration to hemodialysis mainly has an impact on the removal&#xD;
        of larger toxins which benefit of the convective transport. Lowering dialysate flow in&#xD;
        hemodialysis mode mainly has an impact on the removal of small water soluble toxins which are&#xD;
        mainly removed by diffusion. For this transport, different parameters are important: blood&#xD;
        and dialysate flow, dimensions of the membrane (surface area and thickness), fiber diameter,&#xD;
        and extra-luminal space, and membrane porosity (Sieving coefficient). This also implies that,&#xD;
        for the same blood and dialysate flow, the choice of the dialyzer will determine toxin&#xD;
        transport. The use of a medium cut-off membrane with smaller and more open fibers might thus&#xD;
        be more adequate in hemodialysis mode than a standard high-flux dialyzer with wider fibers.&#xD;
  &#xD;
        The aim of this study is to quantify instant extraction and overall total solute removal of&#xD;
        representative uremic toxins in hemodiafiltration with a standard high-flux hemodialyzer&#xD;
        versus hemodialysis with a medium cut-off membrane, either with a standard or reduced&#xD;
        dialysate flow.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dialysis efficiency</measure>
      <time_frame>three midweek dialysis sessions (3 arms)</time_frame>
      <description>Dialyzer extraction and total solute removal are measured and calculated for different uremic toxins</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Uremic Syndrome</condition>
    <arm_group>
      <arm_group_label>Hemodiafiltration with high-flux dialyzer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients are dialysed at midweek using hemodiafiltration (autoflow) with an FX800 Cordiax high-flux dialyzer, with dialysate flow of 700mL/min</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hemodialysis with medium cut-off dialyzer and high dialysate flow</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 700mL/min</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hemodialysis with medium cut-off dialyzer and low dialysate flow</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 300mL/min</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood and dialysate sampling</intervention_name>
      <description>Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.&#xD;
  Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.&#xD;
  Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.</description>
      <arm_group_label>Hemodiafiltration with high-flux dialyzer</arm_group_label>
      <arm_group_label>Hemodialysis with medium cut-off dialyzer and high dialysate flow</arm_group_label>
      <arm_group_label>Hemodialysis with medium cut-off dialyzer and low dialysate flow</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  stable chronic hemodialysis patient&#xD;
  &#xD;
            -  well functioning vascular access&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  active infection&#xD;
  &#xD;
            -  malignancies&#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>Van Biesen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Ghent</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ghent University Hospital</name>
        <address>
          <city>Gent</city>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dialysis efficiency</keyword>
    <keyword>lowered dialysis fluid</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dialysis Solutions</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974436
  org study id: ONZ-2023-0170
  nct id: NCT05974436
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hemodialysis patients consume per year 18.720-26.208L of dialysis fluid (i.e. water). From an
        ecological point of view, the present study investigated whether reducing this water amount
        has an impact on the extraction and total solute removal of different uremic toxins. The
        efficiency of hemodiafiltration with a standard high-flux dialyzer is compared to
        hemodialysis with a medium cut-off dialyzer with a dialysate flow of either 700mL/min or
        300mL/min.
  Hemodialysis is currently performed with dialysate flows in the range 500 and 700mL/min
        respectively in hemodialysis and hemodiafiltration mode. With a standard daytime dialysis
        scheme of three times four hours a week, each patient consumes up to 360-504L dialysate per
        week or 18.720-26.208L per year.
  
        From an ecological point of view, one can wonder whether patients can be dialyzed adequately
        enough using hemodialysis mode with a lower dialysate flow, and as such consuming less water.
  
        Changing the mode from hemodiafiltration to hemodialysis mainly has an impact on the removal
        of larger toxins which benefit of the convective transport. Lowering dialysate flow in
        hemodialysis mode mainly has an impact on the removal of small water soluble toxins which are
        mainly removed by diffusion. For this transport, different parameters are important: blood
        and dialysate flow, dimensions of the membrane (surface area and thickness), fiber diameter,
        and extra-luminal space, and membrane porosity (Sieving coefficient). This also implies that,
        for the same blood and dialysate flow, the choice of the dialyzer will determine toxin
        transport. The use of a medium cut-off membrane with smaller and more open fibers might thus
        be more adequate in hemodialysis mode than a standard high-flux dialyzer with wider fibers.
  
        The aim of this study is to quantify instant extraction and overall total solute removal of
        representative uremic toxins in hemodiafiltration with a standard high-flux hemodialyzer
        versus hemodialysis with a medium cut-off membrane, either with a standard or reduced
        dialysate flow.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dialysis efficiency
  time frame: three midweek dialysis sessions (3 arms)
  description: Dialyzer extraction and total solute removal are measured and calculated for different uremic toxins
  arm group label: Hemodiafiltration with high-flux dialyzer
  arm group type: Experimental
  description: Patients are dialysed at midweek using hemodiafiltration (autoflow) with an FX800 Cordiax high-flux dialyzer, with dialysate flow of 700mL/min
  arm group label: Hemodialysis with medium cut-off dialyzer and high dialysate flow
  arm group type: Experimental
  description: Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 700mL/min
  arm group label: Hemodialysis with medium cut-off dialyzer and low dialysate flow
  arm group type: Experimental
  description: Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 300mL/min
  intervention type: Other
  intervention name: Blood and dialysate sampling
  description: Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.
  Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.
  Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.
  arm group label: Hemodiafiltration with high-flux dialyzer
  arm group label: Hemodialysis with medium cut-off dialyzer and high dialysate flow
  arm group label: Hemodialysis with medium cut-off dialyzer and low dialysate flow
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Van Biesen, PhD
  role: Principal Investigator
  affiliation: University Hospital, Ghent
  facility: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Dialysis Solutions