Critical IllnessNCT03019913
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
An observational study of Critical Illness, run by La Trobe University at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Observational cohort
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2017to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adults
Who may be able to join
- Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
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).
Read the detailed 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.
- Conditions
- Critical Illness
- Being tested
- Observational cohort
- Keywords
- Skeletal muscle
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohortOther
Evaluation of bedside methods to measure muscularity in critically ill patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
Measured: 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)
Measured: <48 hours after CT scan containing L3 area
Secondary outcomes (6)
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
Measured: <48 hours after CT scan containing L3 area
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
Measured: <48 hours after CT scan containing L3 area
Mid arm muscle circumference (cm)
Measured: <48 hours after CT scan containing L3 area
Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
Measured: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Measured resting energy expenditure (kilojoules)
Measured: <48 hours after CT scan containing L3 area
Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
Measured: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Trobe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred
- Responsible party
- Principal investigator, Kate Lambell, La Trobe University
- Investigators
- Kate Lambell, MNutrDiet, Principal investigator, La Trobe University and Alfred Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019913
- Sponsor's protocol ID
- 523/16
- Status last verified
- Mar 2019
- First submitted
- 11 Jan 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 32291773
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03019913
- Acronym / sponsor ID
- 523/16
- Conditions
- Critical Illness
- Keywords
- Skeletal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- La Trobe UniversityUniversity, hospital or other
- Collaborators
- The Alfred
- Study start
- Jan 2017
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adults
Key inclusion criteria (1 listed)
- Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational cohortEvaluation of bedside methods to measure muscularity in critically ill patients | Other | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 32291773Lambell 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.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Lambell, MNutrDiet principal investigator
La Trobe University and Alfred Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by La Trobe University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.