Relation Between Bioelectrical Impedance Analysis (BIA) and CT-scan Analysis in the ICU

Muscular Atrophy Clinical Trial

— ICUBIACT  

Official title:

Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555670
• Other study ID #: ICUBIACT
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: May 9, 2016
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

Aim of the present study is to determine whether muscle mass as assessed by bioelectrical impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan analysis in critically patients admitted to the intensive care unit.

Description:

BIA measurements are performed in critically ill patients admitted to the ICU or MC, within 72 hours before or after CT scanning.

The BIA measurements are taken with the BIA 101 ASE, manufactured by Akern, Florence-7 Italy. This device is phase sensitive and injects an alternating current of 400 µA at 50 kHz. Measurements were performed while patients lay in supine position with a pillow supporting the head. The resistance, reactance, body weight and length are entered in the BIA algorithm, using BodyGram PRO. This algorithm calculated the body composition, with muscle mass being reported in kilogram (kg).

Abdominal CT scans are analyzed using the computer program SliceOmatic® version 4.3 and 5.0 (TomoVision, Montreal, QC, Canada) at the level of the third lumbar vertebra (L3). The muscle tissue was identified by using boundaries in Hounsfield Units (grayscale) set of -29 to +150(23). The program computes muscle surface area in cm2, by multiplying the pixel area by the amount of pixels identified as muscle.

For a direct comparison with the BIA-derived muscle mass, the CT-derived muscle area is converted to kg. This is done by following two steps. Firstly, the Shen equation is used for the conversion to litres.Secondly, the muscle volume is multiplied by its density, resulting in muscle mass expressed in kg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Abdominal CT-scan made for diagnostic reasons

Exclusion Criteria:

• CT-scan not analysable

• Internal or external metal devices

• active pacemaker

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscular Atrophy

Intervention

Other:
• BIA
Bioelectrical impedance analysis was performed within 4 days after a CT-scan was made

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

References & Publications (1)

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	Agreement between BIA-derived muscle mass and CT-derived muscle mass	Agreement will be calculated using a Bland-Altman plot	Patient's data from the ICU-stay will be used, an average of one week	No
Secondary	Sensitivity of BIA to identify low muscle patients	Using CT-derived cut-off points, sensitivity of BIA to identify the same patients as having low muscle will be calculated	Patient's data from the ICU-stay will be used, an average of one week	No
Secondary	Specificity of BIA to identify low muscle patients	Using CT-derived cut-off points, specificity of BIA to identify the same patients as having low muscle will be calculated	Patient's data from the ICU-stay will be used, an average of one week	No
Secondary	Correlation between BIA-derived muscle mass and CT-derived muscle mass	Correlation will be calculated using Pearson's r	Patient's data from the ICU-stay will be used, an average of one week	No