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

Not Applicable

Completed

• Conditions: End Stage Liver Disease

• Registration Number: NCT00374582
• Lead Sponsor: University of Cincinnati

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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States