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

Body Composition Clinical Trial

— USVALID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03160222
• Other study ID #: 1848/2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2019

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: September 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Critical Illness
• Ultrasound

Intervention

Other:
• Body Composition Measurements
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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (6)

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. — View 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. Review. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Jul;40(5):742. — View 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. Epub 2005 Oct 19. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	BIA measurement once-only within 48 hours after the CT scan
Secondary	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.	BIA measurement once-only within 48 hours after the CT scan
Secondary	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.	repeated US measurement in 60 patients once-only within 48 hours after the CT scan
Secondary	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.	repeated US measurement in 60 patients once-only within 48 hours after the CT scan
Secondary	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.	muscle strength measurement once-only within 48 hours after the CT scan