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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

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]

523/16

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical Illness

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)

Timepoint [1]

CT performed for clinical reasons =24 hours before or =72 hours after ICU admission

Primary outcome [2]

Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)

Timepoint [2]

<48 hours after CT scan containing L3 area

Secondary outcome [1]

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

Timepoint [1]

<48 hours after CT scan containing L3 area

Secondary outcome [2]

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

Timepoint [2]

<48 hours after CT scan containing L3 area

Secondary outcome [3]

Mid arm muscle circumference (cm)

Timepoint [3]

<48 hours after CT scan containing L3 area

Secondary outcome [4]

Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)

Timepoint [4]

CT performed for clinical reasons =24 hours before or =72 hours after ICU admission

Secondary outcome [5]

Measured resting energy expenditure (kilojoules)

Timepoint [5]

<48 hours after CT scan containing L3 area

Secondary outcome [6]

Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)

Timepoint [6]

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?

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

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

La Trobe University

Address

Country

Other collaborator category [1]

Other

Name [1]

The Alfred

Address [1]

Country [1]

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

Kate Lambell, MNutrDiet

Address

La Trobe University and Alfred Health

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03019913

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03019913