- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00955500
Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Effect of the Proteins of the Diet in Patients With Cirrhosis and a Prior Episode of Hepatic Encephalopathy. A Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
Barcelona, Spain, 08025
- Hospital de Sant Pau
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Corporacio Sanitaria Parc Tauli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Normal-protein diet
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams).
|
30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
|
ACTIVE_COMPARATOR: Low-protein diet
Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine
|
30 grams of oral maltodextrin daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hepatic encephalopathy-free survival
Time Frame: 56 weeks
|
56 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall duration in days of episodic hepatic encephalopathy
Time Frame: 56 weeks
|
56 weeks
|
Minimal hepatic encephalopathy assessed by neuropsychological tests
Time Frame: 56 weeks
|
56 weeks
|
Health-related quality of life
Time Frame: 56 weeks
|
56 weeks
|
Nutritional status
Time Frame: 56 weeks
|
56 weeks
|
Liver function
Time Frame: 56 weeks
|
56 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(HG)61/2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatic Encephalopathy
-
Jinnah Postgraduate Medical CentreNot yet recruitingHepatic Encephalopathy Stage 2 | Hepatic Encephalopathy Stage 3 | Hepatic Encephalopathy Stage 4Pakistan
-
Sherief Abd-ElsalamTanta UniversityUnknownEncephalopathy, HepaticEgypt
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterInstituto Grifols, S.A.; McGuire Research InstituteCompletedHepatic Encephalopathy | Cirrhosis | Minimal Hepatic Encephalopathy | Covert Hepatic EncephalopathyUnited States
-
Institute of Liver and Biliary Sciences, IndiaWithdrawnRefractory Hepatic EncephalopathyIndia
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Aga Khan UniversityUnknownEncephalopathy, Hepatic | Hepatocerebral Encephalopathy | Portal-Systemic Encephalopathy | Encephalopathy, HepatocerebralPakistan
-
Consorci Sanitari de l'Alt Penedès i GarrafWithdrawn
-
Ain Shams UniversityCompletedMinimal Hepatic Encephalopathy
-
Mansoura UniversityCompletedMinimal Hepatic EncephalopathyEgypt
-
Shanghai Changzheng HospitalEnrolling by invitationHepatic Encephalopathy | Covert Hepatic EncephalopathyChina
Clinical Trials on Branched-chain amino acids
-
University of Western Ontario, CanadaSuspended
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
University Hospital, GenevaCompleted
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Montana State UniversityM.J. Murdoch Charitable Trust; Kreighbaum EndowmentCompleted
-
Beth Israel Deaconess Medical CenterNational Institute of Mental Health (NIMH)Completed
-
Mahidol UniversityRecruitingDecompensated Cirrhosis and AscitesThailand
-
University of TorontoCompletedHealthy | Increased Metabolic Requirement
-
Charles University, Czech RepublicCompletedType 2 Diabetes Mellitus With Features of Insulin ResistanceCzech Republic
-
Kyungpook National University HospitalSamil Pharmaceutical Co., Ltd.UnknownLiver CirrhosisKorea, Republic of