Trial | NCT01041755  Report issue

Title

Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.
The Infusion of L-Ornithine L-aspart is as Effective as Nonabsorbable Disaccharides in the Management of Acute Hepatic Encephalopathy.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the reduction in hepatocellular function and generation of portosystemic shunts contribute to increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood ammonium levels.

Administration of the non-absorbable disaccharides, have become standard treatment of hepatic encephalopathy.There are no adequate clinical trials comparing the efficacy of L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute hepatic encephalopathy.
The main impact of hepatic encephalopathy in patients with cirrhosis is not related to costs, but its association with decreased survival and quality of life and should therefore clearly established the effectiveness of therapeutic interventions used in this disorder.

At the end of the nineteenth century to the ammonium was identified as the main agent responsible for the development of the syndrome of hepatic encephalopathy. Since then, reduced nitrogen compounds from the intestine are considered the main therapeutic measure. On this conceptual base, nonabsorbable disaccharides are the first line therapy in hepatic encephalopathy.

Current knowledge indicates that other organs such as muscle, brain and kidney are involved in the generation of ammonium, which has set the pace for the development of new treatments, able to act systemically in metabolism and elimination of ammonia . L-ornithine L-aspartate (LOLA) lowers ammonium concentrations in animal and humans models with hyperammonemia. There are no adequate clinical trials comparing the efficacy of LOLA infusion against lactose enemas in the treatment of acute hepatic encephalopathy.
Study Started
Nov 30
2009
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
May 10
2021

Drug L-ornithine-L-aspartate

a) Intravenous infusion of 20 g L-ornithine-L-aspartate (4 ampules of 10 mL each) in 250 mL sodium chloride solution administered daily in 4 hours for 3 consecutive days, plus the placebo b) Water enemas, 1000 mL of water and given as retention enema every 12 hours for 3 consecutive days.

  • Other names: LOLA

Drug Lactose

a) 20% Lactose enemas, 200 g Lactose diluted with 700 mL of water and given as retention enema every 12 hours for 3 consecutive days, plus intravenous placebo b)250 mL sodium chloride solution, infusion for 4 hours for 3 consecutive days.

Intravenous infusion of L- Ornithine L- Aspartate Experimental

a) 20 g L-ornithine-L-aspartate

Lactose enemas Active Comparator

b) 20% Lactose enemas

Criteria 

Inclusion Criteria:

Patients with cirrhosis of any etiology, diagnosed by ultrasound,clinical and / or histologic criteria
Patients over 18 years and under 75
Patients with hepatic encephalopathy grade 3-4 according to the criteria of West Haven
Patients with hyperammonemia >10 µmol/l

Exclusion Criteria:

Evidence of neurological or psychiatric illness
Use of drugs affecting the central nervous system
Withdrawal Syndrome
Anorectal disease that interferes with the administration of enemas
No Results Posted