- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555670
Relation Between Bioelectrical Impedance Analysis (BIA) and CT-scan Analysis in the ICU (ICUBIACT)
Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients
Study Overview
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Abdominal CT-scan made for diagnostic reasons
Exclusion Criteria:
- CT-scan not analysable
- Internal or external metal devices
- active pacemaker
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BIA and CT
Patients who had a CT-scan made for diagnostic reasons.
|
Bioelectrical impedance analysis was performed within 4 days after a CT-scan was made
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement between BIA-derived muscle mass and CT-derived muscle mass
Time Frame: Patient's data from the ICU-stay will be used, an average of one week
|
Agreement will be calculated using a Bland-Altman plot
|
Patient's data from the ICU-stay will be used, an average of one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of BIA to identify low muscle patients
Time Frame: Patient's data from the ICU-stay will be used, an average of one week
|
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
|
Specificity of BIA to identify low muscle patients
Time Frame: Patient's data from the ICU-stay will be used, an average of one week
|
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
|
Correlation between BIA-derived muscle mass and CT-derived muscle mass
Time Frame: Patient's data from the ICU-stay will be used, an average of one week
|
Correlation will be calculated using Pearson's r
|
Patient's data from the ICU-stay will be used, an average of one week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wilhelmus Looijaard, MD, Amsterdam UMC, location VUmc
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICUBIACT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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