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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03019913
Registration number
NCT03019913
Ethics application status
Date submitted
11/01/2017
Date registered
13/01/2017
Date last updated
27/03/2019
Titles & IDs
Public title
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
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Scientific title
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
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Secondary ID [1]
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523/16
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Observational cohort
Other interventions: Observational cohort
Evaluation of bedside methods to measure muscularity in critically ill patients
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
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Assessment method [1]
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Timepoint [1]
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CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
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Primary outcome [2]
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Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
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Assessment method [2]
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Timepoint [2]
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<48 hours after CT scan containing L3 area
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Secondary outcome [1]
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Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
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Assessment method [1]
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Timepoint [1]
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<48 hours after CT scan containing L3 area
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Secondary outcome [2]
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Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
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Assessment method [2]
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Timepoint [2]
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<48 hours after CT scan containing L3 area
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Secondary outcome [3]
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Mid arm muscle circumference (cm)
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Assessment method [3]
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Timepoint [3]
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<48 hours after CT scan containing L3 area
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Secondary outcome [4]
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Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
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Assessment method [4]
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Timepoint [4]
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CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
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Secondary outcome [5]
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Measured resting energy expenditure (kilojoules)
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Assessment method [5]
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Timepoint [5]
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<48 hours after CT scan containing L3 area
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Secondary outcome [6]
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Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
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Assessment method [6]
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Timepoint [6]
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CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
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Eligibility
Key inclusion criteria
- Have had a CT scan of the L3 vertebra performed for clinical reasons =24 hours before
or =72 hours after ICU admission
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- CT scan performed >48hrs ago
- Death is imminent or deemed highly likely in the next 96 hours
- Are known to be pregnant
- Treating clinician does not believe the study to be in the best interest of the
patient
- It is not possible to image two or more muscle groups via ultrasound (i.e. due to
trauma, burns, wounds)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2019
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
La Trobe University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03019913
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kate Lambell, MNutrDiet
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Address
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La Trobe University and Alfred Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03019913
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