End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374582

Enrollment

Registered

2006-09-11

Start date

2006-09-30

Completion date

2008-05-31

Last updated

2011-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Liver Disease

Keywords

Bioelectric impedance analysis, BIA, ESLD, LVP, Large volume paracentesis, Ascites, Liver, Hepatic

Brief summary

The purpose of this research study is to see how effective bioelectric impedance analysis (BIA) is in determining body composition (the amount of fat versus muscle in the body) and nutritional status in patients with End Stage Liver Disease (ESLD)

Detailed description

The aim of this study is to report the validity of mBIA to determine body composition changes pre and post LVP (Large Volume Paracentesis) * 18 years of age or older * Cirrhotic patients with refractory ascites requiring LVP (a treatment to remove large volumes of excess fluid from the abdominal cavity) * End Stage Liver Disease

Interventions

DEVICEBodystat Quadscan 4000

device determining body composition and nutritional status

DEVICEbodystat quadscan 400

device determining body composition and nutritional status

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with ESLD requiring LVP. * Age over 18. * Ability to provide written informed consent.

Exclusion criteria

* Organ retransplant candidates. * Patient with use of any investigational agent within 30 days before LVP. * Pregnant or lactating. * Patients with non-bioprosthetic heart valves pacemakers, defibrillators, artificial joints, pins, plates, or other types of metal objects in the body. * Amputations other than fingers or toes.

Design outcomes

Primary

Measure	Time frame
Efficacy and utility of BIA in determining body composition and nutritional status using multi-frequency machines in patients with ESLD and ascites requiring LVP.	Before and after large volume paracentesis

Secondary

Measure	Time frame
Quantify the difference in BIA pre and post LVP to evaluate the impact of oncotic pressure in the assessment of total body composition.	Before and after large volume paracentis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026