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UltrasoundUSVALIDNCT03160222

Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients

A study testing Body Composition Measurements in people with Ultrasound and Body Composition, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (CT) scan including the L3 level for any clinical reason. Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within 48 hours. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ultrasound, Body Composition
What is being tested?
Body Composition Measurements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteAustria
Study dates
Jan 2017to Sep 2019
Phase
Interventional
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

Who may be able to join

  • cross-sectional abdominal CT scan including the level of L3 vertebra for any clinical reason
  • study-related ultrasound examination must take place within 48 hours of CT

Who cannot join

  • patients younger than 18 years

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, 1180

Other trials in Austria

About this study

Official title: Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients: The USVALID Prospective Study

The prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (CT) scan including the L3 level for any clinical reason. Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within 48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle strength, mobility, physical function and nutrition will be assessed. Primary outcome is the prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra- and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat mass. The relationship between clinical aspects (strength, mobility, physical function, nutrition) and whole body composition is another secondary outcome.

Being tested
Body Composition Measurements
Keywords
reliability, bioelectrical impedance analysis, computed tomography, strength, mobility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Body Composition MeasurementsOther

    Body composition measurements comprise the ultrasound measurement of fat and muscle thickness of both upper arms and thighs, the bioelectrical impedance analysis (BIA), measurement of weight, handgrip strength, overall muscle strength (Medical Research Council scale) and questionnaires about physical activity, nutrition and fluid status.

Study groups in NCT03160222
Study groupRoleWhat they receive
Body Composition MeasurementsOtherBody composition measurements comprise the ultrasound measurement of fat and muscle thickness of both upper arms and thighs, the bioelectrical impedance analysis (BIA), measurement of weight, handgrip strength, overall muscle strength (Medical Research Council scale) and questionnaires about physical activity, nutrition and fluid status.
Receives: Other: Body Composition Measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prediction (r2) of CT-based whole body muscle volume from ultrasound-based muscle thickness

    In a linear regression model, the dependent variable is CT-based whole body muscle volume. The independent variable is ultrasound-based muscle thickness. The prediction (r2) of CT-based muscle volume in the multiple linear regression model is the outcome.

    Measured: Ultrasound measurement once-only within 48 hours after the CT scan

  2. prediction (r2) of CT-based whole body fat volume from ultrasound-based fat thickness

    In a linear regression model, the dependent variable is CT-based whole body fat volume. The independent variable is ultrasound-based fat thickness. The prediction (r2) of CT-based fat volume in the multiple linear regression model is the outcome.

    Measured: Ultrasound measurement once-only within 48 hours after the CT scan

Secondary outcomes (5)

  1. prediction (r2) of BIA-based whole body muscle volume from ultrasound-based muscle thickness

    In a linear regression model, the dependent variable is BIA-based whole body muscle volume. The independent variable is ultrasound-based muscle thickness. The prediction (r2) of BIA-based muscle volume in the multiple linear regression model is the outcome.

    Measured: BIA measurement once-only within 48 hours after the CT scan

  2. prediction (r2) of BIA-based whole body fat volume from ultrasound-based fat thickness

    In a linear regression model, the dependent variable is BIA-based whole body fat volume. The independent variable is ultrasound-based fat thickness. The prediction (r2) of BIA-based fat volume in the multiple linear regression model is the outcome.

    Measured: BIA measurement once-only within 48 hours after the CT scan

  3. intrarater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness

    For intrarater reliability each of the 5 examiners repeats the ultrasound measurement in 12 patients. In a Bland Altman analysis, the mean difference (=bias) in muscle/fat thickness between repeated measurements of the same examiner is the outcome.

    Measured: repeated US measurement in 60 patients once-only within 48 hours after the CT scan

  4. interrater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness

    For interrater reliability each of the 10 different pairs of examiners analyzes 6 patients. For each pair both examiners perform the ultrasound examination. In a Bland Altman analysis, the mean difference (=bias) in ultrasound muscle/fat thickness between examiners is the outcome.

    Measured: repeated US measurement in 60 patients once-only within 48 hours after the CT scan

  5. muscle strength in patients with different CT-based body compositions (sarcopenia, malnutrition, obesity, sarcopenic obesity)

    Muscle strength is measured with MRC scale and hand dynamometry. The outcome is muscle strength evaluated in different patient's group according to their CT-based body composition. Sarcopenia is defined as lowered L3 skeletal muscle index. Malnutrition is defined at a BMI beneath18,5 kg/m². Obesity is defined as a BMI above or equal to 30 kg/m². Sarcopenia obesity is defined as lowered L3 skeletal muscle indices and a BMI above or equal to 30 kg/m2.

    Measured: muscle strength measurement once-only within 48 hours after the CT scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study startJan 2017
  3. Primary completion22 Mar 2019
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03160222
Sponsor's protocol ID
1848/2016
Acronym
USVALID
Status last verified
Aug 2019
First submitted
30 Dec 2016
Last updated
30 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Shen W, Punyanitya M, Wang Z, Gallagher D, St-Onge MP, Albu J, Heymsfield SB, Heshka S. Visceral adipose tissue: relations between single-slice areas and total volume. Am J Clin Nutr. 2004 Aug;80(2):271-8. doi: 10.1093/ajcn/80.2.271.

    PubMed 15277145

  • Sanada K, Kearns CF, Midorikawa T, Abe T. Prediction and validation of total and regional skeletal muscle mass by ultrasound in Japanese adults. Eur J Appl Physiol. 2006 Jan;96(1):24-31. doi: 10.1007/s00421-005-0061-0. Epub 2005 Oct 19.

    PubMed 16235068

  • Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.

    PubMed 24410863

  • Paris MT, Mourtzakis M, Day A, Leung R, Watharkar S, Kozar R, Earthman C, Kuchnia A, Dhaliwal R, Moisey L, Compher C, Martin N, Nicolo M, White T, Roosevelt H, Peterson S, Heyland DK. Validation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient (VALIDUM Study). JPEN J Parenter Enteral Nutr. 2017 Feb;41(2):171-180. doi: 10.1177/0148607116637852. Epub 2016 Jul 11.

    PubMed 26962061

  • Prado CM, Heymsfield SB. Lean tissue imaging: a new era for nutritional assessment and intervention. JPEN J Parenter Enteral Nutr. 2014 Nov;38(8):940-53. doi: 10.1177/0148607114550189. Epub 2014 Sep 19.

    PubMed 25239112

  • Takai Y, Ohta M, Akagi R, Kato E, Wakahara T, Kawakami Y, Fukunaga T, Kanehisa H. Applicability of ultrasound muscle thickness measurements for predicting fat-free mass in elderly population. J Nutr Health Aging. 2014;18(6):579-85. doi: 10.1007/s12603-013-0419-7.

    PubMed 24950147

Questions about this trial

What is this clinical trial studying?

A study testing Body Composition Measurements in people with Ultrasound and Body Composition, run by Medical University of Vienna at 1 site in Austria.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 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 Austria. 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?

Results are not available in the source record.

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?

prediction (r2) of CT-based whole body muscle volume from ultrasound-based muscle thickness (time frame: Ultrasound measurement once-only within 48 hours after the CT scan). 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 NCT03160222, which also lists 6 linked publications.

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 30 Aug 2019.

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