L-ornithine L-aspartate in Overt Hepatic Encephalopathy
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
Hepatic encephalopathy (HE) is a potentially reversible functional disorder of the brain with
neurological and psychiatric symptoms. HE occurs in up to 70% of patients with cirrhosis at
some time during the course of disease. The chief neurotoxin implicated in the development of
HE is ammonia. An important aim of treatment of HE is the reduction of the ammonia in the
body by lowering the amount of ammonia produced and increasing its detoxification. Enteric
production of ammonia can be decreased by non-absorbable disaccharides such as lactulose and
antibiotics such as rifaximin. L-ornithine- L-aspartate (LOLA), the salt of the natural amino
acids ornithine and aspartate acts through the mechanism of substrate activation to detoxify
ammonia. In clinical trials, LOLA has shown a statistically significant effect with respect
to reduction in HE grade, reduction of blood ammonia concentration and positive effects on
psychomotor function in patients of cirrhosis with minimal HE and overt chronic Grade I HE,
as compared to placebo. However, there is lack of data on the efficacy of LOLA in patients
with overt acute hepatic encephalopathy which is one of the major causes of hospital
admissions and resource utilization in decompensated cirrhotics. Each admission for HE causes
a major financial loss to the family and financial burden on the society. Any drug which
decreases the hospital stay by rapidly improving HE, will clearly lead to decreased hospital
costs to the individual and the society as a whole. Hence, such a trial is a national
priority. The investigators hypothesize that LOLA, if added to the standard treatment of
overt acute HE (i.e lactulose), may lead to a faster recovery and decrease in hospital stay
of these patients. In this prospective, randomized, placebo controlled trial, the
investigators aim to evaluate the efficacy of intravenous L-ornithine, L-aspartate in
reversal of overt acute hepatic encephalopathy in patients with liver cirrhosis.