<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/NCT03269825</url>
  </required_header>
  <id_info>
    <org_study_id>17/WA/0166</org_study_id>
    <nct_id>NCT03269825</nct_id>
  </id_info>
  <brief_title>The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO</brief_title>
  <official_title>The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
      This is a retrospective, observational study and will investigate the clinical predictive&#xD;
      value of and change in muscle quantity and quality in critically ill patients with severe&#xD;
      respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory&#xD;
      failure - mainly hypoxaemia - has increased over recent years. Similar to the general&#xD;
      population in the Intensive Care Unit (ICU), these patients become deconditioned, severely&#xD;
      weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection&#xD;
      from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this&#xD;
      specific group is lacking.&#xD;
&#xD;
      Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As&#xD;
      all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest,&#xD;
      abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of&#xD;
      different muscle groups of the abdomen at admission and then using any follow-up CT scan&#xD;
      performed within 10 days. In addition, the relationship between the loss of muscle over the&#xD;
      course of VV-ECMO and perceived recovery of renal function at ICU discharge will be&#xD;
      investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>On ECMO (expected to be about 10 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ECMO duration</measure>
    <time_frame>The total duration on ECMO (expected to be an average of 10 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU admission</measure>
    <time_frame>The total duration of ICU admission (expected to be around 2 weeks)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>The total duration of hospital admission (expected to be around 28 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ventilation</measure>
    <time_frame>Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge destination</measure>
    <time_frame>After discharge from hospital (expected to be around 28 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential changes in the muscle quantity over time</measure>
    <time_frame>The total duration of ECMO (expected to be around 10 days)</time_frame>
    <description>Using total muscle quantity measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential changes in muscle quality over time</measure>
    <time_frame>The total duration of ECMO (expected to be around 10 days)</time_frame>
    <description>Using total muscle quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between muscle loss and total nutrition received</measure>
    <time_frame>The total duration of ECMO (expected to be around 10 days)</time_frame>
    <description>Using total muscle quantity measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between muscle loss and rehabilitation goals met</measure>
    <time_frame>The total duration of ECMO (expected to be around 10 days)</time_frame>
    <description>Using total muscle quantity measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Intensive Care Unit Stay (expected to be about 2 weeks)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>6 months post-ICU discharge</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Hospital discharge (expected to be about 28 days)</time_frame>
    <description>Using total muscle quantity and quality measured from CT slice of the third lumbar region.</description>
  </secondary_outcome>
  <enrollment type="Actual">215</enrollment>
  <condition>Critical Illness</condition>
  <condition>Muscle Atrophy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Critically ill patients with severe respiratory failure requiring VV-ECMO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had&#xD;
             one or more CT scans of their abdomen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did&#xD;
             not have one or more CT scans of their abdomen&#xD;
&#xD;
          -  Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have&#xD;
             a poor quality CT scan not analysable by the software&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Danielle E Bear, MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guy's and St Thomas' NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Danielle Bear</investigator_full_name>
    <investigator_title>HEE / NIHR Clinical Doctoral Fellow and Critical Care Dietitian</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <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/NCT03269825
org study id: 17/WA/0166
nct id: NCT03269825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective, observational study and will investigate the clinical predictive
      value of and change in muscle quantity and quality in critically ill patients with severe
      respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).
The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory
      failure - mainly hypoxaemia - has increased over recent years. Similar to the general
      population in the Intensive Care Unit (ICU), these patients become deconditioned, severely
      weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection
      from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this
      specific group is lacking.

      Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As
      all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest,
      abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of
      different muscle groups of the abdomen at admission and then using any follow-up CT scan
      performed within 10 days. In addition, the relationship between the loss of muscle over the
      course of VV-ECMO and perceived recovery of renal function at ICU discharge will be
      investigated.
observational model: Cohort
time perspective: Retrospective
measure: All cause mortality
time frame: On ECMO (expected to be about 10 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Length of ECMO duration
time frame: The total duration on ECMO (expected to be an average of 10 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Length of ICU admission
time frame: The total duration of ICU admission (expected to be around 2 weeks)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Length of hospital stay
time frame: The total duration of hospital admission (expected to be around 28 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Length of ventilation
time frame: Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Discharge destination
time frame: After discharge from hospital (expected to be around 28 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: Sequential changes in the muscle quantity over time
time frame: The total duration of ECMO (expected to be around 10 days)
description: Using total muscle quantity measured from CT slice of the third lumbar region.
measure: Sequential changes in muscle quality over time
time frame: The total duration of ECMO (expected to be around 10 days)
description: Using total muscle quality measured from CT slice of the third lumbar region.
measure: Relationship between muscle loss and total nutrition received
time frame: The total duration of ECMO (expected to be around 10 days)
description: Using total muscle quantity measured from CT slice of the third lumbar region.
measure: Relationship between muscle loss and rehabilitation goals met
time frame: The total duration of ECMO (expected to be around 10 days)
description: Using total muscle quantity measured from CT slice of the third lumbar region.
measure: All cause mortality
time frame: Intensive Care Unit Stay (expected to be about 2 weeks)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: All cause mortality
time frame: 6 months post-ICU discharge
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
measure: All cause mortality
time frame: Hospital discharge (expected to be about 28 days)
description: Using total muscle quantity and quality measured from CT slice of the third lumbar region.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Danielle E Bear, MRes
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Guy's and St Thomas' NHS Foundation Trust
investigator full name: Danielle Bear
investigator title: HEE / NIHR Clinical Doctoral Fellow and Critical Care Dietitian
mesh term: Muscular Atrophy
mesh term: Critical Illness
sharing ipd: No