<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/NCT03239093</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03239093</nct_id>
  </id_info>
  <brief_title>Sixteen Years Trends in Reported Undernutrition in Switzerland</brief_title>
  <official_title>Sixteen Years Trends in Reported Undernutrition in Switzerland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess 16-year trends in undernutrition reporting and management in Switzerland&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The&#xD;
      database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it&#xD;
      covers 98% of public and private hospitals within Switzerland and includes all stays for each&#xD;
      hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 29, 2017</completion_date>
  <primary_completion_date type="Actual">July 29, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>undernutrition reporting</measure>
    <time_frame>1998-2014</time_frame>
    <description>ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nutritional management</measure>
    <time_frame>1998-2014</time_frame>
    <description>CHOP codes related to enteral nutrition (96.6 and 96.35), parenteral nutrition (99.15), nutritional advice and therapy (89.0A.30, 89.0A.31 or 89.0A.32, depending on year) and multimodal nutritional therapy (89.0A.4*, where *=any number).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of stay</measure>
    <time_frame>1998-2014</time_frame>
    <description>Overall length of hospital stay, in days</description>
  </other_outcome>
  <other_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>1998-2014</time_frame>
    <description>Hospital mortality (code=deceased)</description>
  </other_outcome>
  <other_outcome>
    <measure>Nosocomial infection</measure>
    <time_frame>1998-2014</time_frame>
    <description>ICD-10 codes T80.2 (Infections following infusion, transfusion and therapeutic injection); T82.6 (Infection and inflammatory reaction due to cardiac valve prosthesis); T82.7 (Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts); T83.5 (Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system); T83.6 (Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract); T84.5 (Infection and inflammatory reaction due to internal joint prosthesis); T84.6 (Infection and inflammatory reaction due to internal fixation device [any site]); T84.7 (Infection and inflammatory reaction due to other internal orthopaedic prosthetic devices, implants and grafts); T85.7 (Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts); A04.7 (Clostridium difficile infection);</description>
  </other_outcome>
  <enrollment type="Actual">13297188</enrollment>
  <condition>Malnutrition</condition>
  <condition>Epidemiology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Observational study using official data from the Federal Office of Statistics</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalizations representing 98% of public and private hospitals within Switzerland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (aged ≥20 years), length of hospital stay &gt;1 day, not having any ICD-10&#xD;
             codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning&#xD;
             with letter &quot;O&quot;) as main diagnosis, and having complete demographic data and&#xD;
             information on main diagnosis and mortality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Pedro Marques-Vidal</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data request must be sent to the Swiss Federal Office of Statistics (http://www.bfs.admin.ch) and must comply with Swiss data protection rules</ipd_description>
  </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/NCT03239093
org study id: 1
nct id: NCT03239093
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess 16-year trends in undernutrition reporting and management in Switzerland
Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The
      database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it
      covers 98% of public and private hospitals within Switzerland and includes all stays for each
      hospital.
observational model: Ecologic or Community
time perspective: Retrospective
measure: undernutrition reporting
time frame: 1998-2014
description: ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia).
measure: nutritional management
time frame: 1998-2014
description: CHOP codes related to enteral nutrition (96.6 and 96.35), parenteral nutrition (99.15), nutritional advice and therapy (89.0A.30, 89.0A.31 or 89.0A.32, depending on year) and multimodal nutritional therapy (89.0A.4*, where *=any number).
measure: Length of stay
time frame: 1998-2014
description: Overall length of hospital stay, in days
measure: In-hospital mortality
time frame: 1998-2014
description: Hospital mortality (code=deceased)
measure: Nosocomial infection
time frame: 1998-2014
description: ICD-10 codes T80.2 (Infections following infusion, transfusion and therapeutic injection); T82.6 (Infection and inflammatory reaction due to cardiac valve prosthesis); T82.7 (Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts); T83.5 (Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system); T83.6 (Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract); T84.5 (Infection and inflammatory reaction due to internal joint prosthesis); T84.6 (Infection and inflammatory reaction due to internal fixation device [any site]); T84.7 (Infection and inflammatory reaction due to other internal orthopaedic prosthetic devices, implants and grafts); T85.7 (Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts); A04.7 (Clostridium difficile infection);
intervention type: Other
intervention name: No intervention
description: Observational study using official data from the Federal Office of Statistics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Pedro Marques-Vidal
investigator title: Associate professor
mesh term: Malnutrition
sharing ipd: No
ipd description: Data request must be sent to the Swiss Federal Office of Statistics (http://www.bfs.admin.ch) and must comply with Swiss data protection rules