Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02555670
Other study ID # ICUBIACT
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02912130 - Exercise and Nutrition Interventions in Age-related Sarcopenia N/A
Completed NCT01344135 - Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy N/A
Completed NCT04147741 - Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults. N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Active, not recruiting NCT03540732 - Feeding With Indirect Calorimetry and Cycling in the Elderly N/A
Not yet recruiting NCT02568020 - LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD Phase 4
Completed NCT01820702 - Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation N/A
Completed NCT00787098 - Investigating Modes of Progressive Mobility Phase 2
Recruiting NCT04067167 - Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases N/A
Not yet recruiting NCT05769088 - Effects of a Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing in Adults. N/A
Recruiting NCT06053229 - Effect of Percussive Massage on Skeletal Muscle During Limb Immobilization N/A
Not yet recruiting NCT01373697 - Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel Phase 3
Recruiting NCT05481346 - Effects of Multidomain Training of Health With Aging (Train-Old) N/A
Completed NCT02495727 - Two Weeks of Reduced Activity and Skeletal Muscle Health in Older Men N/A
Completed NCT01369511 - A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement Phase 2
Completed NCT02984332 - Timecourse of Immobilization Experiment N/A
Completed NCT02566590 - Preventing the Loss of Muscle and Function in Hospitalized Older Adults N/A
Completed NCT02034942 - Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function N/A
Completed NCT01788111 - Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots. N/A
Completed NCT01791010 - Effects of Inspiratory Muscle Training in Elders N/A