Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Information source: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Encephalopathy
Intervention: Branched-chain amino acids (Dietary Supplement); Maltodextrin (Dietary Supplement)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital Universitari Vall d'Hebron Research Institute Official(s) and/or principal investigator(s): Juan Córdoba, MD, Principal Investigator, Affiliation: Hospital Vall d'Hebron
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 episode of hepatic encephalopathy within two months prior to inclusion.
Clinical Details
Official title: Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Hepatic encephalopathy-free survival
Secondary outcome: Overall duration in days of episodic hepatic encephalopathyMinimal hepatic encephalopathy assessed by neuropsychological tests Health-related quality of life Nutritional status Liver function
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 plasma ammonia. The gastrointestinal tract is the primary source of ammonia,
which is produced by enterocytes from glutamine and by colonic bacterial catabolism of
nitrogenous sources, such as ingested proteins. This is the rationale for proposing
low-protein diet as strategy to reduce ammonia production and as standard diet in patients
with cirrhosis and hepatic encephalopathy. However, low-protein diet could cause wasting
muscle and predispose to recurrence of hepatic encephalopathy, since muscle is an important
site for extrahepatic ammonia removal.
Branched-chain amino acids have shown beneficial effects on mental state of patients with
chronic hepatic encephalopathy. The possible mechanism of action may be improvement of
nutritional status through induction of protein synthesis. However, role of branched-chain
amino acids in treatment and prevention of acute hepatic encephalopathy is not established.
Administration of a normal-protein diet containing oral branched-chain amino acids may
reduce recurrence of hepatic encephalopathy as compared to a low-protein diet.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Hospital de Sant Pau, Barcelona 08025, Spain
Hospital del Mar, Barcelona 08003, Spain
Corporació Sanitària Parc Taulí, Sabadell, Barcelona 08208, Spain
Additional Information
Starting date: January 2003
Last updated: August 7, 2009
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