Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Regional para el Estudio de las Enfermedades Digestivas
• Collaborator: MERZ PHARMA
• Treatments: N-Methylaspartate

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