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/NCT05984069</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN962022/CHUSTE</org_study_id>
      <nct_id>NCT05984069</nct_id>
    </id_info>
    <brief_title>Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported</brief_title>
    <acronym>FICUF</acronym>
    <official_title>Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom&#xD;
        reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have&#xD;
        been described, including ICU-acquired weakness, leading to increased morbidity and mortality&#xD;
        after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are&#xD;
        not really known.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frailty, defined as a decrease in physiological reserves leading to an alteration in the&#xD;
        mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a&#xD;
        cause of post-ICU fatigue self-reported.&#xD;
  &#xD;
        The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU&#xD;
        story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged&#xD;
        ICU stays.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Frailty</measure>
      <time_frame>1 year</time_frame>
      <description>Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>1 year</time_frame>
      <description>Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU-acquired weakness and fatigue</measure>
      <time_frame>1 year</time_frame>
      <description>Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue, quality of life, anxiety and depressive disorder</measure>
      <time_frame>1 year</time_frame>
      <description>Correlation between fatigue, quality of life, anxiety and depressive disorder</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kinetic of muscle mass loss and post-ICU fatigue self-reported</measure>
      <time_frame>1 year</time_frame>
      <description>Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Post Intensive Care Syndrome</condition>
    <arm_group>
      <arm_group_label>Patients on etiologies</arm_group_label>
      <description>Patients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>observational prospective data collection</intervention_name>
      <description>Collection of data from medical records.</description>
      <arm_group_label>Patients on etiologies</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted to intensive care, all etiologies combined, excluding immediate&#xD;
          post-operative scheduled surgery, with mechanical ventilation for more than 5 days or&#xD;
          length of stay in ICU over 10 days.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a length of stay in intensive care &gt; or equal to 7 days, or mechanical&#xD;
               ventilation &gt; or equal to 5 days&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scheduled surgery with admission in ICU&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Guardianship&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jérôme MOREL, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jérôme MOREL, MD PhD</last_name>
      <phone>(0)477828553</phone>
      <phone_ext>+33</phone_ext>
      <email>jerome.morel@chu-st-etienne.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nory ELHADJENE, resident</last_name>
      <phone>(0)477828553</phone>
      <phone_ext>+33</phone_ext>
      <email>nory.saint-etienne@wanadoo.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Chu Saint-Etienne</name>
        <address>
          <city>Saint-etienne</city>
          <zip>42000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jérôme MOREL, MD PhD</last_name>
        <phone>(0)4 77 82 85 53</phone>
        <phone_ext>+33</phone_ext>
        <email>jerome.morel@chu-st-etienne.fr</email>
      </contact>
      <investigator>
        <last_name>Jérôme MOREL, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nory ELHADJENE, resident</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intensive Care Unit</keyword>
    <keyword>frailty</keyword>
    <keyword>fatigue</keyword>
    <keyword>ICU acquired-weakness</keyword>
    <keyword>FACIT-F</keyword>
    <keyword>physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue</mesh_term>
      <mesh_term>Frailty</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/NCT05984069
  org study id: IRBN962022/CHUSTE
  nct id: NCT05984069
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom
        reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have
        been described, including ICU-acquired weakness, leading to increased morbidity and mortality
        after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are
        not really known.
  Frailty, defined as a decrease in physiological reserves leading to an alteration in the
        mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a
        cause of post-ICU fatigue self-reported.
  
        The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU
        story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged
        ICU stays.
  observational model: Cohort
  time perspective: Prospective
  measure: Frailty
  time frame: 1 year
  description: Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported
  measure: Fatigue
  time frame: 1 year
  description: Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort
  measure: ICU-acquired weakness and fatigue
  time frame: 1 year
  description: Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test
  measure: Fatigue, quality of life, anxiety and depressive disorder
  time frame: 1 year
  description: Correlation between fatigue, quality of life, anxiety and depressive disorder
  measure: Kinetic of muscle mass loss and post-ICU fatigue self-reported
  time frame: 1 year
  description: Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported
  arm group label: Patients on etiologies
  description: Patients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included
  intervention type: Other
  intervention name: observational prospective data collection
  description: Collection of data from medical records.
  arm group label: Patients on etiologies
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jérôme MOREL, MD PhD
  role: Principal Investigator
  affiliation: CHU Saint Etienne
  last name: Jérôme MOREL, MD PhD
  phone: (0)477828553
  phone ext: +33
  email: jerome.morel@chu-st-etienne.fr
  last name: Nory ELHADJENE, resident
  phone: (0)477828553
  phone ext: +33
  email: nory.saint-etienne@wanadoo.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Fatigue
  mesh term: Frailty
  sharing ipd: No