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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Secondary ID [1] 0 0
523/16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational cohort

Other interventions: Observational cohort
Evaluation of bedside methods to measure muscularity in critically ill patients
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
Timepoint [1] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
Primary outcome [2] 0 0
Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
Timepoint [2] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [1] 0 0
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
Timepoint [1] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [2] 0 0
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
Timepoint [2] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [3] 0 0
Mid arm muscle circumference (cm)
Timepoint [3] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [4] 0 0
Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
Timepoint [4] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission
Secondary outcome [5] 0 0
Measured resting energy expenditure (kilojoules)
Timepoint [5] 0 0
<48 hours after CT scan containing L3 area
Secondary outcome [6] 0 0
Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
Timepoint [6] 0 0
CT performed for clinical reasons =24 hours before or =72 hours after ICU admission

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2019
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT03019913
Trial related presentations / publications
Lambell KJ, Tierney AC, Wang JC, Nanjayya V, Forsyth A, Goh GS, Vicendese D, Ridley EJ, Parry SM, Mourtzakis M, King SJ. Comparison of Ultrasound-Derived Muscle Thickness With Computed Tomography Muscle Cross-Sectional Area on Admission to the Intensive Care Unit: A Pilot Cross-Sectional Study. JPEN J Parenter Enteral Nutr. 2021 Jan;45(1):136-145. doi: 10.1002/jpen.1822. Epub 2020 Apr 15.
Public notes

Contacts
Principal investigator
Name 0 0
Kate Lambell, MNutrDiet
Address 0 0
La Trobe University and Alfred Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03019913