Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: N-Methylaspartate

Criteria

Inclusion Criteria:

• Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis,

• Patients >14 years, with HE grades 1 to 4 according to West Haven Criteria,

• Hyperammonemia (fasting venous blood ammonia level >60 µmol/l), and

• Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none.

Exclusion Criteria:

• hepatocellular carcinoma,

• severe septicemia,

• active gastrointestinal bleeding,

• hepatorenal syndrome,

• acute superimposed liver injury,

• advanced cardiac or pulmonary disease and end stage renal failure,

• patients with minimal HE

• patients taking sedatives, antidepressants, or benzodiazepines and

• patients with chronic HE on metronidazole or lactulose prior to admission.