NCT03160222

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

December 30, 2016

Last Update Submit

August 28, 2019

Conditions

UltrasoundBody Composition

Keywords

reliabilitybioelectrical impedance analysiscomputed tomographystrengthmobility

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

Body Composition Measurements

OTHER

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.

Other: Body Composition Measurements

Interventions

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.

Body Composition Measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1180, Austria

Location

Related Publications (6)

  • 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.

    PMID: 15277145BACKGROUND

  • 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.

    PMID: 16235068BACKGROUND

  • 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.

    PMID: 24410863BACKGROUND

  • 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.

    PMID: 26962061BACKGROUND

  • 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.

    PMID: 25239112BACKGROUND

  • 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.

    PMID: 24950147BACKGROUND

Study Officials

  • Arabella Fischer, Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Michael Hiesmayr, Prof. Dr.

    Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 30, 2016

First Posted

May 19, 2017

Study Start

January 1, 2017

Primary Completion

March 22, 2019

Study Completion

September 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)