Back to resultsEnd Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)
Primary Purpose
End Stage Liver Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodystat Quadscan 4000
bodystat quadscan 400
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Liver Disease focused on measuring Bioelectric impedance analysis, BIA, ESLD, LVP, Large volume paracentesis, Ascites, Liver, Hepatic
Eligibility 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.
Sites / Locations
- University of Cincinnati
Outcomes
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.
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.
Full Information
NCT ID
NCT00374582
First Posted
September 8, 2006
Last Updated
March 3, 2011
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00374582
Brief Title
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)
Official Title
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
Keywords
Bioelectric impedance analysis, BIA, ESLD, LVP, Large volume paracentesis, Ascites, Liver, Hepatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Bodystat Quadscan 4000
Intervention Description
device determining body composition and nutritional status
Intervention Type
Device
Intervention Name(s)
bodystat quadscan 400
Intervention Description
device determining body composition and nutritional status
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Neff, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Learn more about this trial
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)
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