<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/NCT03037138</url>
  </required_header>
  <id_info>
    <org_study_id>BenhaU</org_study_id>
    <nct_id>NCT03037138</nct_id>
  </id_info>
  <brief_title>Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients</brief_title>
  <official_title>Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New Jeddah Clinic Hospital</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Benha University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The&#xD;
      aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis&#xD;
      washed-out state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood&#xD;
      flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50&#xD;
      ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9&#xD;
      dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale&#xD;
      from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate&#xD;
      profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to&#xD;
      compare washed out scale before and after together with urea reduction rate and other blood&#xD;
      chemistry tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2016</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Washed-out Scale</measure>
    <time_frame>after 9 modified dialysis session (21 dyas from start of study)</time_frame>
    <description>Scale of washed-out degree after dialysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urea reduction Rate</measure>
    <time_frame>after 9 modified dialysis session (21 dyas from start of study)</time_frame>
    <description>change in urea reduction rate after use of blood flow rate profiling</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Hemodialysis-Induced Symptom</condition>
  <arm_group>
    <arm_group_label>Washed-out scale after using BFR profiling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood flow profiling will be used as intervention for washed-out dialysis patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood flow Rate profiling</intervention_name>
    <description>Blood flow rate profiling during dialysis session</description>
    <arm_group_label>Washed-out scale after using BFR profiling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemodialysis Patient&#xD;
&#xD;
          -  Postdialysis washed-out complain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  schedule-non complaint patients&#xD;
&#xD;
          -  Patients with recent blood pressure drug modification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Mahmoud Hamada imam</investigator_full_name>
    <investigator_title>Lecturer of Nephrology in Internal Medicine Department</investigator_title>
  </responsible_party>
  <keyword>postdialysis washed-out</keyword>
  <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/NCT03037138
org study id: BenhaU
nct id: NCT03037138
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The
      aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis
      washed-out state.
Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood
      flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50
      ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9
      dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale
      from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate
      profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to
      compare washed out scale before and after together with urea reduction rate and other blood
      chemistry tests.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
primary purpose: Prevention
masking: None (Open Label)
measure: Washed-out Scale
time frame: after 9 modified dialysis session (21 dyas from start of study)
description: Scale of washed-out degree after dialysis
measure: Urea reduction Rate
time frame: after 9 modified dialysis session (21 dyas from start of study)
description: change in urea reduction rate after use of blood flow rate profiling
arm group label: Washed-out scale after using BFR profiling
arm group type: Other
description: Blood flow profiling will be used as intervention for washed-out dialysis patients
intervention type: Other
intervention name: Blood flow Rate profiling
description: Blood flow rate profiling during dialysis session
arm group label: Washed-out scale after using BFR profiling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Mahmoud Hamada imam
investigator title: Lecturer of Nephrology in Internal Medicine Department
sharing ipd: No