Muscular AtrophyICUBIACTNCT02555670
Relation Between Bioelectrical Impedance Analysis (BIA) and CT-scan Analysis in the ICU
An observational study of Muscular Atrophy, run by Amsterdam UMC, location VUmc.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- BIA
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Adult Intensive Care Unit
Who may be able to join
- Abdominal CT-scan made for diagnostic reasons
Who cannot join
- CT-scan not analysable
- Internal or external metal devices
- active pacemaker
About this study
Official title: Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients
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.
Read the 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.
- Conditions
- Muscular Atrophy
- Being tested
- BIA
- Keywords
- Muscles, Intensive Care, Tomography, X-Ray Computed, Electric Impedance
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIAOther
Also called Bioelectrical impedance analysis
Bioelectrical impedance analysis was performed within 4 days after a CT-scan was made
| Study group | Role | What they receive |
|---|---|---|
| BIA and CT | Patients who had a CT-scan made for diagnostic reasons. Receives: Other: BIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between BIA-derived muscle mass and CT-derived muscle mass
Agreement will be calculated using a Bland-Altman plot
Measured: Patient's data from the ICU-stay will be used, an average of one week
Secondary outcomes (3)
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
Measured: Patient's data from the ICU-stay will be used, an average of one week
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
Measured: 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
Correlation will be calculated using Pearson's r
Measured: Patient's data from the ICU-stay will be used, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilhelmus G.P.M. Looijaard, MD, Amsterdam UMC, location VUmc
- Investigators
- Wilhelmus Looijaard, MD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555670
- Sponsor's protocol ID
- ICUBIACT
- Acronym
- ICUBIACT
- Status last verified
- May 2016
- First submitted
- 17 Sep 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 24410863Looijaard 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.
PubMed 31492456
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02555670
- Acronym / sponsor ID
- ICUBIACT / ICUBIACT
- Conditions
- Muscular Atrophy
- Keywords
- Muscles, Intensive Care, Tomography, X-Ray Computed, Electric Impedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIA and CT | – | Other: BIAPatients who had a CT-scan made for diagnostic reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Adult Intensive Care Unit
Key inclusion criteria (1 listed)
- Abdominal CT-scan made for diagnostic reasons
Key exclusion criteria (3 listed)
- CT-scan not analysable
- Internal or external metal devices
- active pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIAAlso: Bioelectrical impedance analysisBioelectrical impedance analysis was performed within 4 days after a CT-scan was made | Other | BIA and CT |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 24410863Weijs 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.
- Derived from this study: PubMed 31492456Looijaard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelmus Looijaard, MD principal investigator
Amsterdam UMC, location VUmc
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Atrophy, run by Amsterdam UMC, location VUmc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.