Clinical trial NCT03160222: Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients
Official title: Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients: The USVALID Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasound
Body Composition
Keywords: reliability
bioelectrical impedance analysis
computed tomography
strength
mobility
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* patients younger than 18 years

Primary outcomes:
measure: prediction (r2) of CT-based whole body muscle volume from ultrasound-based muscle thickness
timeFrame: Ultrasound measurement once-only within 48 hours after the CT scan
measure: prediction (r2) of CT-based whole body fat volume from ultrasound-based fat thickness
timeFrame: Ultrasound measurement once-only within 48 hours after the CT scan
Secondary outcomes:
measure: prediction (r2) of BIA-based whole body muscle volume from ultrasound-based muscle thickness
timeFrame: BIA measurement once-only within 48 hours after the CT scan
measure: prediction (r2) of BIA-based whole body fat volume from ultrasound-based fat thickness
timeFrame: BIA measurement once-only within 48 hours after the CT scan
measure: intrarater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness
timeFrame: repeated US measurement in 60 patients once-only within 48 hours after the CT scan
measure: interrater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness
timeFrame: repeated US measurement in 60 patients once-only within 48 hours after the CT scan
measure: muscle strength in patients with different CT-based body compositions (sarcopenia, malnutrition, obesity, sarcopenic obesity)
timeFrame: muscle strength measurement once-only within 48 hours after the CT scan
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Arabella Fischer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Michael Hiesmayr, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.