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

End Stage Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374582
• Other study ID #: BIA
• Status: Completed
• Phase: N/A
• First received: September 8, 2006
• Last updated: March 3, 2011
• Start date: September 2006
• Est. completion date: May 2008

Study information

• Verified date: March 2011
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

Device:
• Bodystat Quadscan 4000
device determining body composition and nutritional status
• bodystat quadscan 400
device determining body composition and nutritional status

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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