An observational study in Critical Illness, sponsored by La Trobe University. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by La Trobe University · Observational
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
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 50 is below the median of 140 across 814 observational studies indexed under Critical Illness.
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Critically ill adults
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Exclusion Criteria:
Evaluation of bedside methods to measure muscularity in critically ill patients
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
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
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
Time frame: <48 hours after CT scan containing L3 area
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
Time frame: <48 hours after CT scan containing L3 area
Mid arm muscle circumference (cm)
Time frame: <48 hours after CT scan containing L3 area
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
Measured resting energy expenditure (kilojoules)
Time frame: <48 hours after CT scan containing L3 area
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
Plan to share: Undecided
The record gives a start of Jan 2017, a primary completion of Mar 2019 and a completion of Mar 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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La Trobe University