Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019913
• Other study ID #: 523/16
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: La Trobe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
La Trobe University	The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

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