drugset / Trial / NCT01041755

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

NCT01041755

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-11
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject L-ornithine L-aspartate Other / unclassified 20 g Intravenous
Comparator LACTOSE, ANHYDROUS Unknown 20 % Rectal
Comparator LACTOSE, ANHYDROUS Unknown 200 g Rectal