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/NCT05978154</url>
    </required_header>
    <id_info>
      <org_study_id>musclemassandwastingined</org_study_id>
      <nct_id>NCT05978154</nct_id>
    </id_info>
    <brief_title>Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department</brief_title>
    <official_title>Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Korea University Ansan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Korea University Ansan Hospital</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>
        The goal of this observational study is to evaluate whether thigh muscle mass and muscle&#xD;
        wasting are associated with mortality in patients who visit the emergency department. The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  Is thigh muscle mass associated with mortality in patient who visit the emergency&#xD;
             department?&#xD;
  &#xD;
          -  Does muscle wasting exist during staying in the emergency department?&#xD;
  &#xD;
          -  Is muscle wasting associated with mortality in patient who visit the emergency&#xD;
             department? Participants will be evaluated for serial thigh muscle mass using&#xD;
             point-of-care ultrasound at the emergency department.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>28 day mortality</measure>
      <time_frame>28 days after study enrollment</time_frame>
      <description>28 day mortality</description>
    </primary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Sepsis</condition>
    <condition>Cardiac Arrest</condition>
    <condition>Acute Respiratory Failure</condition>
    <condition>Patients Who Visit Emergency Department</condition>
    <condition>Shock</condition>
    <condition>Trauma</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Thigh muscle mass and muscle wasting (exposure)</intervention_name>
      <description>Thigh muscle mass and muscle wasting (exposure variable)</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who visit the emergency department with informed consent and then who undergo&#xD;
          point-of-care ultrasound to evaluate thigh muscle mass.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients who visit the emergency department of Korea University Ansan Hospital during&#xD;
               study period&#xD;
  &#xD;
            -  patients with age within the limits&#xD;
  &#xD;
            -  patients who are willing to be participate the study with informed consent&#xD;
  &#xD;
            -  patients who undergo point-of-care ultrasound to evaluate thigh muscle mass&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with age out of limits&#xD;
  &#xD;
            -  patients who have deformities on lower leg&#xD;
  &#xD;
            -  patients who is unable to maintain appropriate position to undergo point-of-care&#xD;
               ultrasound&#xD;
  &#xD;
            -  patients who decline to participate the study&#xD;
  &#xD;
            -  patients who have 'do-not-resuscitate' order or are not willing to be resuscitated&#xD;
  &#xD;
            -  patients of whom point-of-care ultrasound on thigh muscle mass was not performed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sejoong Ahn</last_name>
      <phone>82-10-2946-0250</phone>
      <email>sejongahn@naver.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Korea University Ansan Hospital</name>
        <address>
          <city>Ansan-si</city>
          <state>Gyeonggi-do</state>
          <zip>15355</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sejoong Ahn</last_name>
        <email>sejoongahn@naver.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Korea University Ansan Hospital</investigator_affiliation>
      <investigator_full_name>Ahn, Sejoong</investigator_full_name>
      <investigator_title>Korea University Ansan Hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Muscular Atrophy</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05978154
  org study id: musclemassandwastingined
  nct id: NCT05978154
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate whether thigh muscle mass and muscle
        wasting are associated with mortality in patients who visit the emergency department. The
        main questions it aims to answer are:
  
          -  Is thigh muscle mass associated with mortality in patient who visit the emergency
             department?
  
          -  Does muscle wasting exist during staying in the emergency department?
  
          -  Is muscle wasting associated with mortality in patient who visit the emergency
             department? Participants will be evaluated for serial thigh muscle mass using
             point-of-care ultrasound at the emergency department.
  observational model: Cohort
  time perspective: Prospective
  measure: 28 day mortality
  time frame: 28 days after study enrollment
  description: 28 day mortality
  intervention type: Other
  intervention name: Thigh muscle mass and muscle wasting (exposure)
  description: Thigh muscle mass and muscle wasting (exposure variable)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sejoong Ahn
  phone: 82-10-2946-0250
  email: sejongahn@naver.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Korea University Ansan Hospital
  investigator full name: Ahn, Sejoong
  investigator title: Korea University Ansan Hospital
  mesh term: Respiratory Insufficiency
  mesh term: Muscular Atrophy
  mesh term: Emergencies
  sharing ipd: No