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Completed

NCT Number: NCT00374582

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

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)

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Key information

Conditions

End Stage Liver Disease Ascites Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bodystat Quadscan 4000

Device

device determining body composition and nutritional status

bodystat quadscan 400

Device

device determining body composition and nutritional status

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2006
Registry last updated
Mar 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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