<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/NCT03026985</url>
  </required_header>
  <id_info>
    <org_study_id>516/16</org_study_id>
    <nct_id>NCT03026985</nct_id>
  </id_info>
  <brief_title>Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO</brief_title>
  <official_title>Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Alfred</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe the changes in quadriceps muscle size and quality&#xD;
      over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound&#xD;
      imaging. This study will also examine the relationship between those changes and muscle&#xD;
      strength and level of physical function at day 10 and day 20 after ECMO commencement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of ECMO has increased dramatically in the past decade with improvements in technology&#xD;
      and survival. Whilst it is a potentially life-saving intervention in a group of patients at&#xD;
      high risk of death, it is both highly invasive and expensive. ECMO poses a dramatic&#xD;
      physiological burden on patients with major long-term consequences. Among these, severe&#xD;
      prolonged neuromuscular weakness is perhaps the most significant complication. Described&#xD;
      clinically as intensive care unit acquired weakness (ICUAW), it is associated with prolonged&#xD;
      weaning from mechanical ventilation, delayed rehabilitation, increased hospital length of&#xD;
      stay, and mortality with residual deficits in physical functional ability persisting up to 5&#xD;
      years following the ICU admission. The health value, to both patients and society, could be&#xD;
      substantially improved if more patients achieved a complete recovery.&#xD;
&#xD;
      Muscle strength testing in the early stages of critical illness is limited, as it requires&#xD;
      the patient to be awake, alert and cognitively intact, therefore delayed diagnosis of ICUAW&#xD;
      due to inability of patients to complete muscle strength testing is common. Consequently,&#xD;
      there is growing interest in the utility of ultrasound imaging to monitor the trajectory of&#xD;
      muscle wasting and inform development of targeted interventions in these critically ill&#xD;
      patients. Ultrasound imaging of skeletal muscle is a non-invasive, painless and radiation&#xD;
      free technique that can provide objective, accurate and reliable data on skeletal muscle in&#xD;
      these critically ill patients. This study will use ultrasound imaging to quantify the early&#xD;
      change in skeletal muscle size and quality, and the relationship to strength and physical&#xD;
      function in patients on ECMO. Risk stratification of patients with peripheral muscle wasting&#xD;
      is vital for optimising clinical management, including development of improved rehabilitative&#xD;
      strategies to improve recovery and optimise the risk/benefit profile of ECMO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">September 19, 2017</completion_date>
  <primary_completion_date type="Actual">September 19, 2017</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>Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO</measure>
    <time_frame>10 days</time_frame>
    <description>Change in quadriceps muscle size</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Critical Illness</condition>
  <condition>Muscle Wasting</condition>
  <condition>Extracorporeal Membrane Oxygenation</condition>
  <arm_group>
    <arm_group_label>Observational cohort</arm_group_label>
    <description>Ultrasound measurement of quadriceps muscle size and echogenicity will be obtained at baseline (within 48 hours of ECMO commencement), 10 days and 20 days after baseline measurement.&#xD;
Measures of muscle strength and highest mobility level will be obtained at day 10 and day 20 after baseline measurement in order to determine the relationship between these volitional measures and the ultrasound parameters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational cohort</intervention_name>
    <description>Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level</description>
    <arm_group_label>Observational cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients admitted to the ICU requiring ECMO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years)&#xD;
&#xD;
          -  Requiring ECMO for management of severe cardiac or respiratory failure&#xD;
&#xD;
          -  Likely to spend &gt; 24 hours on ECMO&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of:&#xD;
&#xD;
          -  Any connective tissue disorders (e.g., Marfan's syndrome)&#xD;
&#xD;
          -  A proven or suspected acute primary brain process that is likely to result in global&#xD;
             impairment of conscious level or cognition, such as traumatic brain injury,&#xD;
             intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or&#xD;
             asphyxiation&#xD;
&#xD;
          -  Any neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal&#xD;
             cord injury, Guillain-Barre syndrome)&#xD;
&#xD;
          -  Any current cancer or chemotherapy&#xD;
&#xD;
          -  A cognitive impairment prior to the acute illness that is associated with admission to&#xD;
             ICU that would impair capacity to follow verbal instructions Any current acute&#xD;
             musculoskeletal injuries of hip, knee, and ankle&#xD;
&#xD;
          -  A pre-existing mobility impairment where the patient is unable to walk without&#xD;
             assistance prior to the acute illness that is associated with admission to ICU (use of&#xD;
             a walking stick or frame is not an exclusion)&#xD;
&#xD;
          -  A language barrier to patient comprehension, or where death is deemed imminent and&#xD;
             inevitable&#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>Kate Hayes</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Alfred</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>September 23, 2017</last_update_submitted>
  <last_update_submitted_qc>September 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Alfred</investigator_affiliation>
    <investigator_full_name>Kate Hayes</investigator_full_name>
    <investigator_title>Senior Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Extracorporeal Membrane Oxygenation</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Intensive Care Units</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Cachexia</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/NCT03026985
org study id: 516/16
nct id: NCT03026985
lead sponsor: 
has dmc: No
The purpose of this study is to describe the changes in quadriceps muscle size and quality
      over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound
      imaging. This study will also examine the relationship between those changes and muscle
      strength and level of physical function at day 10 and day 20 after ECMO commencement.
The use of ECMO has increased dramatically in the past decade with improvements in technology
      and survival. Whilst it is a potentially life-saving intervention in a group of patients at
      high risk of death, it is both highly invasive and expensive. ECMO poses a dramatic
      physiological burden on patients with major long-term consequences. Among these, severe
      prolonged neuromuscular weakness is perhaps the most significant complication. Described
      clinically as intensive care unit acquired weakness (ICUAW), it is associated with prolonged
      weaning from mechanical ventilation, delayed rehabilitation, increased hospital length of
      stay, and mortality with residual deficits in physical functional ability persisting up to 5
      years following the ICU admission. The health value, to both patients and society, could be
      substantially improved if more patients achieved a complete recovery.

      Muscle strength testing in the early stages of critical illness is limited, as it requires
      the patient to be awake, alert and cognitively intact, therefore delayed diagnosis of ICUAW
      due to inability of patients to complete muscle strength testing is common. Consequently,
      there is growing interest in the utility of ultrasound imaging to monitor the trajectory of
      muscle wasting and inform development of targeted interventions in these critically ill
      patients. Ultrasound imaging of skeletal muscle is a non-invasive, painless and radiation
      free technique that can provide objective, accurate and reliable data on skeletal muscle in
      these critically ill patients. This study will use ultrasound imaging to quantify the early
      change in skeletal muscle size and quality, and the relationship to strength and physical
      function in patients on ECMO. Risk stratification of patients with peripheral muscle wasting
      is vital for optimising clinical management, including development of improved rehabilitative
      strategies to improve recovery and optimise the risk/benefit profile of ECMO.
observational model: Cohort
time perspective: Prospective
measure: Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO
time frame: 10 days
description: Change in quadriceps muscle size
arm group label: Observational cohort
description: Ultrasound measurement of quadriceps muscle size and echogenicity will be obtained at baseline (within 48 hours of ECMO commencement), 10 days and 20 days after baseline measurement.
Measures of muscle strength and highest mobility level will be obtained at day 10 and day 20 after baseline measurement in order to determine the relationship between these volitional measures and the ultrasound parameters.
intervention type: Other
intervention name: Observational cohort
description: Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level
arm group label: Observational cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kate Hayes
role: Principal Investigator
affiliation: The Alfred
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The Alfred
investigator full name: Kate Hayes
investigator title: Senior Physiotherapist
mesh term: Muscular Atrophy
mesh term: Wasting Syndrome
mesh term: Critical Illness
mesh term: Cachexia
sharing ipd: No