Clinical Trial: Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of a Three Days’ Infusion of L-Ornithine-L-Aspartate as an Adjuvant Therapy in Cirrhotic Patients With Overt Hepatic Encephalopathy: A Placebo Controlled St
Brief Summary: The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.
Detailed Summary: There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic lobules. Aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for glutamine synthesis, which is performed exclusively by a small population of perivenous hepatocytes, the so-called perivenous scavenger cells. The ammonia lowering effect resulting from the stimulation of these two basic mechanisms of ammonia detoxification has been studied in animals and was confirmed in humans in clinical trials.
Sponsor: Aga Khan University
Current Primary Outcome:
- Improvement in HE grade.
- deterioration in HE grade.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of hospital stay
- fasting ammonia level and
- mortality rate
Original Secondary Outcome: Same as current
Information By: Aga Khan University
Dates:
Date Received: February 8, 2007
Date Started: October 2003
Date Completion: September 2004
Last Updated: February 8, 2007
Last Verified: February 2007
