Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

Data collection

1. Baseline characteristics

   • demographic data; age, gender, BW, height
   • cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
   • comorbidity such as DM, CVA

2. After randomization

   • assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
   • blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
   • record adverse effect of drug such as nausea, vomiting, bloating.
   • record diet, frequency of bowel movement and stool pH
   • compliance

Inclusion Criteria:

• Cirrhosis
• Age 18-80
• Hepatic encephalopathy grade II-III
• Serum ammonia > 60 mcg/mL
• Informed consent

Exclusion Criteria:

• Recent GI hemorrhage
• Severe sepsis
• Degenerative CNS disease or major psychiatric illness
• Serum creatinine > 1.5 mg/dl
• Pregnancy or lactation
• Poorly controlled DM
• Insertion of TIPS
• Received CNS depressants or hypnotics
• Treatment with metronidazole, kanamycin or branched-chain amino acid
• Hypersensitivity to L-ornithine-L-aspartate