Factors Associated With End Stage Liver Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
100 ambulatory patients with cirrhosis will be prospectively evaluated for severity of liver disease, anemia, and fatigue; exclusion criteria includes chronic renal insufficiency and recent alcohol use, gastrointestinal bleeding, and infection.
Patients will first be identified and be asked to partake in the study. They will be asked to read over an informed consent form. Subsequently, they will be asked to fill out a depression questionnaire before performing the 6MWT. During the 6MWT the patient will be walking up and down two designated points 100 feet apart. They will be asked to walk for 6 minutes using any walking aids and resting as needed. Their final distance will be recorded. They will then be asked to fill out the FIS fatigue questionnaire.
Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, hepatic encephalopathy, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), standard liver tests (TBili, Albumin, INA), platelet count as a parameter of splenic sequestration and portal hypertension, Child-Pugh score, MELD (Model of End-stage Liver Disease) score. Anemia will be assessed with hemoglobin levels. Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. Sexual function will be assessed by the Sexual Problems and Sexual Function scales of the LDQOL. The results will be scored and compared to depression quality of life, and end-stage liver disease factors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ambulatory cirrhotic patients Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), laboratory tests (TBili, Albumin, INR, hemoglobin). Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. |
Outcome Measures
Primary Outcome Measures
- Fatigue [20 minutes]
Patients undergo 6 minute walk test and complete Fisk Impact Scale (Fatigue Questionaire)
Secondary Outcome Measures
- Hepatic Encephalopathy [20 minutes]
Patients do psychometric tests (Number Connection Test, Symbol Digit Coding Test, and Inhibitory Control Test)
- Depression [5 min]
Patients complete Beck Depression Inventory Questionnaire
- Quality of Life [10 min]
Patients complete several questionaires (Liver disease quality of Life, EQ-5D, Psychological Well-Being index)
Eligibility Criteria
Criteria
Inclusion Criteria:
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male or female, age b/w 18-70 years, inclusive
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willingly and able to provide written consent
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Diagnosed with Cirrhosis
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Able to read and write in English
Exclusion Criteria:
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Inability to provide consent
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Not within age range of 18-70 years, inclusive
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Not diagnosed with Cirrhosis
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Unable to read or write in English
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Unable to walk
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU School of Medicine, Schwartz Health Care Center Suite 4C | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Samuel Sigal, M.D., NYU Langone Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11-00843