Status:
COMPLETED
Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare a normal-protein diet containing branched-chain amino acids to a low-protein diet in patients with non-terminal cirrhosis (MELD \< 25) who have developed an epi...
Detailed Description
Hepatic encephalopathy is a major complication of cirrhosis associated with poor prognosis and poor quality of life. Appearance of HE occurs in the setting of precipitating factors that increase plasm...
Eligibility Criteria
Inclusion
- Cirrhosis of the liver.
- Recovery from an episode of hepatic encephalopathy within two months prior to inclusion.
- Compliance with a standard diet during two weeks prior to inclusion.
Exclusion
- End-stage cirrhosis (MELD score \> 25).
- Marked cognitive disorder (mini-mental test \< 27).
- Non-treatable hepatocarcinoma in accordance with Milan criteria.
- Comorbid conditions with a life expectancy less than 6 months.
- Neurological conditions that difficult assessment of treatment of hepatic encephalopathy (dementia, encephalitis, severe depression).
- Diseases requiring administration of a specific diet (malabsorption, chronic diarrhea, chronic pancreatic insufficiency, severe obesity).
- No acceptation of written consent.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00955500
Start Date
January 1 2003
End Date
January 1 2009
Last Update
August 10 2009
Active Locations (3)
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1
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
2
Hospital del Mar
Barcelona, Spain, 08003
3
Hospital de Sant Pau
Barcelona, Spain, 08025