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Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03019913
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
Kate Lambell, La Trobe University

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).


Condition or disease Intervention/treatment
Critical Illness Other: Observational cohort

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Study Start Date : January 2017
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Intervention Details:
  • Other: Observational cohort
    Evaluation of bedside methods to measure muscularity in critically ill patients


Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy [ Time Frame: <48 hours after CT scan containing L3 area ]
  2. Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe) [ Time Frame: <48 hours after CT scan containing L3 area ]
  3. Mid arm muscle circumference (cm) [ Time Frame: <48 hours after CT scan containing L3 area ]
  4. 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 ]
  5. Measured resting energy expenditure (kilojoules) [ Time Frame: <48 hours after CT scan containing L3 area ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill adults
Criteria

Inclusion Criteria:

  • Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019913


Locations
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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
La Trobe University
The Alfred
Investigators
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Principal Investigator: Kate Lambell, MNutrDiet La Trobe University and Alfred Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kate Lambell, PhD candidate, Dietitian, La Trobe University
ClinicalTrials.gov Identifier: NCT03019913    
Other Study ID Numbers: 523/16
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kate Lambell, La Trobe University:
Skeletal muscle
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes