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

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00374582
First received: September 8, 2006
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
BIA
ESLD
LVP
Large volume paracentesis
Ascites
Liver
Hepatic

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

ClinicalTrials.gov processed this record on July 24, 2014