<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/NCT03019913</url>
  </required_header>
  <id_info>
    <org_study_id>523/16</org_study_id>
    <nct_id>NCT03019913</nct_id>
  </id_info>
  <brief_title>Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients</brief_title>
  <official_title>Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>La Trobe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>La Trobe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle wasting is a significant problem in critically ill patients, with reported losses of a&#xD;
      half to three percent per day over the first ten days (for an average 70kg person this&#xD;
      equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive&#xD;
      care unit (ICU) and the loss of lean tissue have been associated with negative clinical&#xD;
      outcomes, including increased incidence of infections, length of stay, mortality and muscle&#xD;
      weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients&#xD;
      with low muscularity on admission, 2) to help understand the factors impacting muscle loss&#xD;
      and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass&#xD;
      in this population.&#xD;
&#xD;
      The measurement of lean body mass in patients admitted to the ICU is challenging however, due&#xD;
      to the large fluid shifts that occur in this population and logistical issues in moving&#xD;
      patients to specialised machinery for body composition analysis. Currently, there is no&#xD;
      validated method for accurately assessing a patient's muscle mass at the bedside in the&#xD;
      intensive care setting. It is therefore important to investigate the accuracy, feasibility&#xD;
      and reliability of bedside methods such as subjective physical assessment of muscle mass, mid&#xD;
      arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this&#xD;
      population who are primarily bedbound. In order to do this, a critical comparison is required&#xD;
      between these methods and muscularity assessed by a &quot;reference&quot; body composition method, such&#xD;
      computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the&#xD;
      abdomen area utilising abdominal CT images has been shown to be highly representative of&#xD;
      whole body skeletal muscle volume.&#xD;
&#xD;
      We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a&#xD;
      CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be&#xD;
      to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound,&#xD;
      bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated&#xD;
      with skeletal muscle mass quantified by a &quot;reference method&quot; (CT image analysis).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim Our primary aim is to investigate whether muscularity assessed via bedside ultrasound is&#xD;
      correlated with a reference method for estimating whole body skeletal muscle mass (CT image&#xD;
      analysis) in the first few days of critical illness.&#xD;
&#xD;
      Our secondary aims are&#xD;
&#xD;
        -  To investigate whether muscularity assessed via other bedside methods (bioimpedance&#xD;
           spectroscopy, subjective physical assessment and mid arm muscle circumference) are&#xD;
           correlated with a reference method for estimating whole body skeletal muscle mass (CT&#xD;
           image analysis) in critically ill patients.&#xD;
&#xD;
        -  To better understand the association between measured resting energy expenditure and&#xD;
           muscularity in the critically ill.&#xD;
&#xD;
        -  To observe changes in skeletal muscle mass (in a sub set of patients who have two CT&#xD;
           scans) and the impact various factors, including energy and protein delivery has on&#xD;
           these changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</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>Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)</measure>
    <time_frame>CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)</measure>
    <time_frame>&lt;48 hours after CT scan containing L3 area</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy</measure>
    <time_frame>&lt;48 hours after CT scan containing L3 area</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)</measure>
    <time_frame>&lt;48 hours after CT scan containing L3 area</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid arm muscle circumference (cm)</measure>
    <time_frame>&lt;48 hours after CT scan containing L3 area</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)</measure>
    <time_frame>CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured resting energy expenditure (kilojoules)</measure>
    <time_frame>&lt;48 hours after CT scan containing L3 area</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)</measure>
    <time_frame>CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Critical Illness</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational cohort</intervention_name>
    <description>Evaluation of bedside methods to measure muscularity in critically ill patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before&#xD;
             or ≤72 hours after ICU admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CT scan performed &gt;48hrs ago&#xD;
&#xD;
          -  Death is imminent or deemed highly likely in the next 96 hours&#xD;
&#xD;
          -  Are known to be pregnant&#xD;
&#xD;
          -  Treating clinician does not believe the study to be in the best interest of the&#xD;
             patient&#xD;
&#xD;
          -  It is not possible to image two or more muscle groups via ultrasound (i.e. due to&#xD;
             trauma, burns, wounds)&#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 Lambell, MNutrDiet</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Trobe University and Alfred Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>La Trobe University</investigator_affiliation>
    <investigator_full_name>Kate Lambell</investigator_full_name>
    <investigator_title>PhD candidate, Dietitian</investigator_title>
  </responsible_party>
  <keyword>Skeletal muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03019913
org study id: 523/16
nct id: NCT03019913
lead sponsor: 
collaborator: 
has dmc: Yes
Muscle wasting is a significant problem in critically ill patients, with reported losses of a
      half to three percent per day over the first ten days (for an average 70kg person this
      equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive
      care unit (ICU) and the loss of lean tissue have been associated with negative clinical
      outcomes, including increased incidence of infections, length of stay, mortality and muscle
      weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients
      with low muscularity on admission, 2) to help understand the factors impacting muscle loss
      and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass
      in this population.

      The measurement of lean body mass in patients admitted to the ICU is challenging however, due
      to the large fluid shifts that occur in this population and logistical issues in moving
      patients to specialised machinery for body composition analysis. Currently, there is no
      validated method for accurately assessing a patient's muscle mass at the bedside in the
      intensive care setting. It is therefore important to investigate the accuracy, feasibility
      and reliability of bedside methods such as subjective physical assessment of muscle mass, mid
      arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this
      population who are primarily bedbound. In order to do this, a critical comparison is required
      between these methods and muscularity assessed by a "reference" body composition method, such
      computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the
      abdomen area utilising abdominal CT images has been shown to be highly representative of
      whole body skeletal muscle volume.

      We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a
      CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be
      to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound,
      bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated
      with skeletal muscle mass quantified by a "reference method" (CT image analysis).
Aim Our primary aim is to investigate whether muscularity assessed via bedside ultrasound is
      correlated with a reference method for estimating whole body skeletal muscle mass (CT image
      analysis) in the first few days of critical illness.

      Our secondary aims are

        -  To investigate whether muscularity assessed via other bedside methods (bioimpedance
           spectroscopy, subjective physical assessment and mid arm muscle circumference) are
           correlated with a reference method for estimating whole body skeletal muscle mass (CT
           image analysis) in critically ill patients.

        -  To better understand the association between measured resting energy expenditure and
           muscularity in the critically ill.

        -  To observe changes in skeletal muscle mass (in a sub set of patients who have two CT
           scans) and the impact various factors, including energy and protein delivery has on
           these changes.
observational model: Cohort
time perspective: Prospective
measure: Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
time frame: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
measure: Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
time frame: <48 hours after CT scan containing L3 area
measure: Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
time frame: <48 hours after CT scan containing L3 area
measure: Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
time frame: <48 hours after CT scan containing L3 area
measure: Mid arm muscle circumference (cm)
time frame: <48 hours after CT scan containing L3 area
measure: Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
time frame: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
measure: Measured resting energy expenditure (kilojoules)
time frame: <48 hours after CT scan containing L3 area
measure: Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
time frame: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
intervention type: Other
intervention name: Observational cohort
description: Evaluation of bedside methods to measure muscularity in critically ill patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kate Lambell, MNutrDiet
role: Principal Investigator
affiliation: La Trobe University and Alfred Health
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: La Trobe University
investigator full name: Kate Lambell
investigator title: PhD candidate, Dietitian
mesh term: Critical Illness
sharing ipd: Undecided