Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy
The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 Study|
- Improvement in HE grade.
- deterioration in HE grade.
- Length of hospital stay
- fasting ammonia level and
- mortality rate
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||September 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433368
|Aga Khan University Hospital|
|Karachi, Sind, Pakistan, 74800|
|Study Chair:||Wasim Jafri, MD; FRCP||Chairman Department of Medicine, Aga Khan University Hospital|
|Principal Investigator:||Shahab Abid, MD||Associate Professor, Department of Medicine, Aga Khan University|