Clinical trial NCT02555670: Relation Between Bioelectrical Impedance Analysis (BIA) and CT-scan Analysis in the ICU
Official title: Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Atrophy
Keywords: Muscles
Intensive Care
Tomography, X-Ray Computed
Electric Impedance
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Adult Intensive Care Unit

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Abdominal CT-scan made for diagnostic reasons

Exclusion Criteria:

* CT-scan not analysable
* Internal or external metal devices
* active pacemaker

Primary outcomes:
measure: Agreement between BIA-derived muscle mass and CT-derived muscle mass
timeFrame: Patient's data from the ICU-stay will be used, an average of one week
Secondary outcomes:
measure: Sensitivity of BIA to identify low muscle patients
timeFrame: Patient's data from the ICU-stay will be used, an average of one week
measure: Specificity of BIA to identify low muscle patients
timeFrame: Patient's data from the ICU-stay will be used, an average of one week
measure: Correlation between BIA-derived muscle mass and CT-derived muscle mass
timeFrame: Patient's data from the ICU-stay will be used, an average of one week
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Wilhelmus Looijaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Looijaard WGPM, Stapel SN, Dekker IM, Rusticus H, Remmelzwaal S, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Identifying critically ill patients with low muscle mass: Agreement between bioelectrical impedance analysis and computed tomography. Clin Nutr. 2020 Jun;39(6):1809-1817. doi: 10.1016/j.clnu.2019.07.020. Epub 2019 Aug 10.