NCT00374582

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

September 8, 2006

Last Update Submit

March 3, 2011

Conditions

End Stage Liver Disease

Keywords

Bioelectric impedance analysisBIAESLDLVPLarge volume paracentesisAscitesLiverHepatic

Outcome Measures

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.

    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.

    Before and after large volume paracentis

Interventions

Bodystat Quadscan 4000DEVICE

device determining body composition and nutritional status

bodystat quadscan 400DEVICE

device determining body composition and nutritional status

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ESLD requiring LVP.
  • Age over 18.
  • Ability to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

End Stage Liver DiseaseAscites

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guy Neff, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations

US(1)