Eighty patients were included in a randomized, double-blind, placebo-controlled multicentre trial to determine the effect of L-ornithine-L-aspartate (Hepa-Merz¨) infusion on serum ammonia level in patients with liver cirrhosis accompanied by hyperammonaemia.Fourty patients received ornithine-aspartate (20 g in 250 ml 0,9% NaCl infusion solution administered intravenously during four hours) and 40 patients received placebo (250 ml 5% fructose solution). The follow-up time was seven days. Patients had alcoholic liver cirrhosis with hyperammonaemia (venous ammonia > 50 µmol/l). Patients treated with other hepatotherapeutic agents and those having alcohol withdrawal syndrome, consumption of alcohol during the study, gastrointestinal bleeding, pregnancy, severe concomitant diseases or fructose intolerance were excluded from the trial. Effect of treatment was evaluated by the clinical course and laboratory parameters of patients (venous ammonia level, g-GT, AST, ALT, AP, glucose, bilirubin, ChE, BUN, creatinine, albumin, prothrombin and hematological parameters) measured at 1, 3, 5 and 7 days of treatment.The seven-day ornithine-aspartate infusion therapy resulted in a significant decrease (p<0,05) of fasting ammonia concentration (-32%) when compared with that in the placebo group (-15%). There was no significant improvement in the routine laboratory parameters measured. Good tolerability and low rate of side effects were reported by the patients. In view of its demonstrated effect, ornithine-aspartate infusion can be considered as an effective therapy to decrease elevated serum ammonia level in cirrhotic patients.

Keywords: Liver Cirrhosis, ornithine-aspartate, hyperammonaemia