<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/NCT03772171</url>
  </required_header>
  <id_info>
    <org_study_id>17-250</org_study_id>
    <nct_id>NCT03772171</nct_id>
  </id_info>
  <brief_title>Estimate for Dietary Intakes and Hemodialysis Patients</brief_title>
  <acronym>EDDEN</acronym>
  <official_title>Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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 aim of this clinical research is to evaluate the relevance of using the EPA slide to&#xD;
      estimate dietary intakes in dialysis patients. The obtained results will be compared with the&#xD;
      reference technique validated by the HAS: food intake over 3 days.&#xD;
&#xD;
      The aim is also to improve the global management of dialysis patients and improve their&#xD;
      quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been&#xD;
      demonstrated in hospitals but for which no study has been carried out in an ambulatory&#xD;
      hospitalization context.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients</measure>
    <time_frame>10 days</time_frame>
    <description>The Gold Standard will calculate the energy intake of the patient from the food intake over 3 days, as a percentage of its energy needs, calculated according to the weight of the patient (actual weight if weight &lt;30kg.m² and weight adjusted if weight ≥ 30kg.m²).</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Nutrition Disorders</condition>
  <condition>Dialysis</condition>
  <condition>Chronic Renal Failure</condition>
  <condition>Dietetician</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic end stage renal failure treated by hemodialysis in hemodialysis&#xD;
        center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be able to understand and voluntarily sign an informed consent form&#xD;
&#xD;
          -  Patient with chronic end stage renal failure treated with hemodialysis.&#xD;
&#xD;
          -  Patient with age &gt;= 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient treated by peritoneal dialysis&#xD;
&#xD;
          -  Patient with age &lt; 18 years&#xD;
&#xD;
          -  Patient with intellectual limitations that may limit the comprehension of&#xD;
             questionnaires&#xD;
&#xD;
          -  Patient with communication disorders or verbal comprehension&#xD;
&#xD;
          -  Patient not French speaking&#xD;
&#xD;
          -  Patient with enteral nutrition&#xD;
&#xD;
          -  Patient having been hospitalized for less than 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Néphrology Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03772171
org study id: 17-250
nct id: NCT03772171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this clinical research is to evaluate the relevance of using the EPA slide to
      estimate dietary intakes in dialysis patients. The obtained results will be compared with the
      reference technique validated by the HAS: food intake over 3 days.

      The aim is also to improve the global management of dialysis patients and improve their
      quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been
      demonstrated in hospitals but for which no study has been carried out in an ambulatory
      hospitalization context.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients
time frame: 10 days
description: The Gold Standard will calculate the energy intake of the patient from the food intake over 3 days, as a percentage of its energy needs, calculated according to the weight of the patient (actual weight if weight <30kg.m² and weight adjusted if weight ≥ 30kg.m²).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Nutrition Disorders
sharing ipd: Undecided