Status:
TERMINATED
Quality of Life and Nutritional Improvements in Cirrhotic Patients
Lead Sponsor:
Tampa General Hospital
Conditions:
Liver Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic pa...
Detailed Description
Prevention of portal hypertension complications should be at the forefront. In doing so, the end result will be an improvement in the multitude of morbidity and mortality issues. The proposed prospect...
Eligibility Criteria
Inclusion
- Male and female gender of Age 18 years or older
- Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis
- Model for End Stage Liver Disease (MELD) score \< 20
- Willingness to provide written informed consent, and participate in all study requirements
- Sodium greater than 130 meq/L
- Conn Score \< 2
Exclusion
- Active alcohol consumption
- Serum total bilirubin level \> 5 mg/dl
- History of hepatocellular carcinoma (HCC) and malignancies other than basal cell carcinoma of the skin
- Pregnant or breastfeeding women
- Subject has renal insufficiency requiring routine dialysis
- Poorly controlled diabetes as defined by HgA1C \> 10
- Narcotic/psychotropic usage other than a stable dose of antidepressant and/or methadone. Neurontin (gabapentin) and Lyrica (pregabalin) are permitted if the subject has been on a stable dose for at least 2 months prior to the screening visit and no change of dosing is expected throughout the length of the trial
- Any of the following diagnoses:
- HIV
- Evidence of severe concomitant illness or any condition that makes them unsuitable for the study in the opinion of the investigator(s)
- Subject has received an investigational drug within 30 days prior to enrollment
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01842113
Start Date
April 1 2013
Last Update
September 23 2013
Active Locations (1)
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1
Tampa General Medical Group
Tampa, Florida, United States, 33606