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

This study has been completed.
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
First received: September 8, 2006
Last updated: March 3, 2011
Last verified: March 2011
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)

Condition Intervention
End Stage Liver Disease
Device: Bodystat Quadscan 4000
Device: bodystat quadscan 400

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)

Resource links provided by NLM:

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Efficacy and utility of BIA in determining body composition and nutritional status using multi-frequency machines in patients with ESLD and ascites requiring LVP. [ Time Frame: Before and after large volume paracentesis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantify the difference in BIA pre and post LVP to evaluate the impact of oncotic pressure in the assessment of total body composition. [ Time Frame: Before and after large volume paracentis ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bodystat Quadscan 4000
    device determining body composition and nutritional status
    Device: bodystat quadscan 400
    device determining body composition and nutritional status
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00374582

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Guy Neff, MD University of Cincinnati
  More Information

Responsible Party: Guy Neff, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374582     History of Changes
Other Study ID Numbers: BIA 
Study First Received: September 8, 2006
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Bioelectric impedance analysis
Large volume paracentesis

Additional relevant MeSH terms:
End Stage Liver Disease
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Failure

ClinicalTrials.gov processed this record on May 26, 2016