Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): L-ornithine-L-aspartate; Lactose
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): LOLA
Intervention MeSH terms: N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Encephalopathy; Cirrhosis