NCT02555670

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

September 17, 2015

Last Update Submit

May 9, 2016

Conditions

Keywords

MusclesIntensive CareTomography, X-Ray ComputedElectric Impedance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Sensitivity of BIA to identify low muscle patients

    Patient's data from the ICU-stay will be used, an average of one week

  • Specificity of BIA to identify low muscle patients

    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

    Patient's data from the ICU-stay will be used, an average of one week

Study Arms (1)

BIA and CT

Patients who had a CT-scan made for diagnostic reasons.

Other: BIA

Interventions

BIAOTHER

Bioelectrical impedance analysis was performed within 4 days after a CT-scan was made

Also known as: Bioelectrical impedance analysis
BIA and CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the Adult Intensive Care Unit

You may qualify if:

  • Abdominal CT-scan made for diagnostic reasons

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24410863BACKGROUND
  • 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.

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Wilhelmus Looijaard, MD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 21, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share