Clinical trial NCT00955500: Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Official title: Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: Hepatic encephalopathy
Cirrhosis
Proteins of the diet
Branched-chain amino acids
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 episode of hepatic encephalopathy within two months prior to inclusion.

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 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.

Primary outcomes:
measure: Hepatic encephalopathy-free survival
timeFrame: 56 weeks
Secondary outcomes:
measure: Overall duration in days of episodic hepatic encephalopathy
timeFrame: 56 weeks
measure: Minimal hepatic encephalopathy assessed by neuropsychological tests
timeFrame: 56 weeks
measure: Health-related quality of life
timeFrame: 56 weeks
measure: Nutritional status
timeFrame: 56 weeks
measure: Liver function
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
Study officials:
affiliation: Hospital Vall d'Hebron
name: Juan Córdoba, MD
role: PRINCIPAL_INVESTIGATOR
References: