Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients

NCT03019913 | Completed DMC

• 1 other identifier: 523/16
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness

Keywords

Skeletal muscle

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy

  <48 hours after CT scan containing L3 area

• Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)

  <48 hours after CT scan containing L3 area

• Mid arm muscle circumference (cm)

  <48 hours after CT scan containing L3 area

• 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

• Measured resting energy expenditure (kilojoules)

  <48 hours after CT scan containing L3 area

Interventions

Observational cohort OTHER

Evaluation of bedside methods to measure muscularity in critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• La Trobe University: lead
• The Alfred: collaborator

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 32291773 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kate Lambell, MNutrDiet

  La Trobe University and Alfred Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, Dietitian

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

AU (1)