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Factors Associated With End Stage Liver Disease

NCT01846819 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2017-01-25

No results posted yet for this study

Summary

100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standardized exercise test that measures the distance that a patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to select the factors that potentially are associated with the scores as indicated by a P value \<.20; the selected factors will then be entered in a stepwise regression to create a multivariate model giving the combination of factors that are significantly associated with the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model in order to test its significance while controlling for the other factors.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Samuel Sigal, M.D. · NYU Langone Medical Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846819 on ClinicalTrials.gov