<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/NCT03288285</url>
  </required_header>
  <id_info>
    <org_study_id>106042</org_study_id>
    <nct_id>NCT03288285</nct_id>
  </id_info>
  <brief_title>Comparison of Post- and Pre-dilutional Hemodiafiltration in Hemodialysis Patients</brief_title>
  <official_title>Effects of Post- and Pre-dilutional Hemodiafiltration on Patients With End-stage Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tungs' Taichung Metroharbour Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tungs' Taichung Metroharbour Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal&#xD;
      disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large&#xD;
      and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of&#xD;
      hemodiafiltration include pre-dilution and post-dilution according to the infusion site of&#xD;
      substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of&#xD;
      uremic toxins. However, hemoconcentration and clotting of membrane limit its further&#xD;
      clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic&#xD;
      status. Although lower clearance of small molecule uremic toxins, one study in Japan showed&#xD;
      survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study&#xD;
      was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological&#xD;
      parameters and clearance of uremic toxins by using cross-over study design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study design: randomly assigned, cross-over study.&#xD;
&#xD;
        2. Patient number: 60.&#xD;
&#xD;
        3. Inclusion criteria: stable patients end-stage renal disease who were older than 20 years&#xD;
           and received thrice-weekly standard hemodialysis for more than 3 months were recruited.&#xD;
&#xD;
        4. Exclusion criteria: active systemic disease, liver cirrhosis, active malignancy,&#xD;
           receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter,&#xD;
           inadequate dialysis dose (single-pooled Kt/V&lt;1.2).&#xD;
&#xD;
        5. Methods:&#xD;
&#xD;
           Prior to randomization, a Charlson Comorbidity Index score and baseline characteristics&#xD;
           are recorded for each patient. Each patient who received HDF prior to study will&#xD;
           received one-month high-flux hemodialysis with target single-pooled Kt/V&gt;1.2 for&#xD;
           washout. The baseline characteristics of each patient including dialyzer, dialysis time,&#xD;
           blood flow, dialysate flow, replacement volume, pre- and post-dialysis blood pressure&#xD;
           and body weight were recorded. The follow-up laboratory data will also be collected:&#xD;
           predialysis C-reactive protein, blood urea nitrogen, creatinine, bicarbonate, sodium,&#xD;
           potassium, uric acid, albumin, calcium, phosphate, intact parathyroid hormone,&#xD;
           β2-microglobulin, prolactin, fibroblast growth factor 23, α1-microglobulin, indoxyl&#xD;
           sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation&#xD;
           product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis&#xD;
           factor-α, hematocrit, transferrin saturation and ferritin. Urea kinetics including kt/V,&#xD;
           Urea reduction ratio and normalized protein catabolic rate are calculated. We also used&#xD;
           Physical Symptoms Distress Scale for life quality measurement.&#xD;
&#xD;
           After randomization, two group received standard prescription of pre- and post-dilution&#xD;
           HDF. The prescribed convective volume per treatment of post-dilution mode is based on&#xD;
           blood flow, filtration fraction and hematocrit to achieved current recommendation of 23&#xD;
           liter/1.73m2. The convective volume of pre-dilution mode will be at least twice higher&#xD;
           than the desired dose in post-dilution mode for each patient. After 3-month stable&#xD;
           hemodiafiltration, parameters mentioned above will also be checked. Two group will be&#xD;
           switched for another 3-month course and then switch again. The total following time is&#xD;
           12 months.&#xD;
&#xD;
        6. Outcome: The primary objective is to compare the removal of a wide spectrum of solutes&#xD;
           such as middle and protein-bound molecules. Secondary outcomes are intradialytic&#xD;
           tolerance, including intradialytic hypotension, cramps and arrhythmia, and life quality&#xD;
           measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 7, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Removal of a wide spectrum of solutes</measure>
    <time_frame>1 years</time_frame>
    <description>The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intradialytic tolerance</measure>
    <time_frame>1 years</time_frame>
    <description>intradialytic tolerance including symptomatic hypotension, cramps, headache, nutrition, and inflammatory status.</description>
  </secondary_outcome>
  <enrollment type="Actual">49</enrollment>
  <condition>Hemodiafiltration</condition>
  <eligibility>
    <study_pop>
      <textblock>
        hemodialysis (HD) patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable patients end-stage renal disease who were older than 20 years and received&#xD;
             thrice-weekly standard hemodialysis for more than 3 months were recruited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active systemic disease, liver cirrhosis, malignancy, receiving immunosuppressive&#xD;
             treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose&#xD;
             (kt/V&lt;1.2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-Hsu Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tungs' Taichung Metroharbour Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tungs' Taichung Metroharbour Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemodiafiltration</keyword>
  <keyword>pre-dilution</keyword>
  <keyword>post-dilution</keyword>
  <keyword>uremic toxins</keyword>
  <!-- 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/NCT03288285
org study id: 106042
nct id: NCT03288285
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal
      disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large
      and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of
      hemodiafiltration include pre-dilution and post-dilution according to the infusion site of
      substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of
      uremic toxins. However, hemoconcentration and clotting of membrane limit its further
      clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic
      status. Although lower clearance of small molecule uremic toxins, one study in Japan showed
      survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study
      was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological
      parameters and clearance of uremic toxins by using cross-over study design.
1. Study design: randomly assigned, cross-over study.

        2. Patient number: 60.

        3. Inclusion criteria: stable patients end-stage renal disease who were older than 20 years
           and received thrice-weekly standard hemodialysis for more than 3 months were recruited.

        4. Exclusion criteria: active systemic disease, liver cirrhosis, active malignancy,
           receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter,
           inadequate dialysis dose (single-pooled Kt/V<1.2).

        5. Methods:

           Prior to randomization, a Charlson Comorbidity Index score and baseline characteristics
           are recorded for each patient. Each patient who received HDF prior to study will
           received one-month high-flux hemodialysis with target single-pooled Kt/V>1.2 for
           washout. The baseline characteristics of each patient including dialyzer, dialysis time,
           blood flow, dialysate flow, replacement volume, pre- and post-dialysis blood pressure
           and body weight were recorded. The follow-up laboratory data will also be collected:
           predialysis C-reactive protein, blood urea nitrogen, creatinine, bicarbonate, sodium,
           potassium, uric acid, albumin, calcium, phosphate, intact parathyroid hormone,
           β2-microglobulin, prolactin, fibroblast growth factor 23, α1-microglobulin, indoxyl
           sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation
           product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis
           factor-α, hematocrit, transferrin saturation and ferritin. Urea kinetics including kt/V,
           Urea reduction ratio and normalized protein catabolic rate are calculated. We also used
           Physical Symptoms Distress Scale for life quality measurement.

           After randomization, two group received standard prescription of pre- and post-dilution
           HDF. The prescribed convective volume per treatment of post-dilution mode is based on
           blood flow, filtration fraction and hematocrit to achieved current recommendation of 23
           liter/1.73m2. The convective volume of pre-dilution mode will be at least twice higher
           than the desired dose in post-dilution mode for each patient. After 3-month stable
           hemodiafiltration, parameters mentioned above will also be checked. Two group will be
           switched for another 3-month course and then switch again. The total following time is
           12 months.

        6. Outcome: The primary objective is to compare the removal of a wide spectrum of solutes
           such as middle and protein-bound molecules. Secondary outcomes are intradialytic
           tolerance, including intradialytic hypotension, cramps and arrhythmia, and life quality
           measurements.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: Removal of a wide spectrum of solutes
time frame: 1 years
description: The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules
measure: Intradialytic tolerance
time frame: 1 years
description: intradialytic tolerance including symptomatic hypotension, cramps, headache, nutrition, and inflammatory status.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chang-Hsu Chen, MD
role: Principal Investigator
affiliation: Tungs' Taichung Metroharbour Hospital
facility: 
country: Taiwan
responsible party type: Sponsor