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

May 9, 2016 updated by: Wilhelmus G.P.M. Looijaard, MD, Amsterdam UMC, location VUmc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Adult Intensive Care Unit

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Bioelectrical impedance analysis

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wilhelmus Looijaard, MD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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