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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: L-ornithine-L-aspartate and lactulose; Drug: placebo and lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00740142

Si 341/2008

Details and patient eligibility

About

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

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Interventional arm: oral L-ornithine-L-aspartate and oral lactulose

Treatment:

Drug: L-ornithine-L-aspartate and lactulose

2

Placebo Comparator group

Description:

Oral lactulose

Treatment:

Drug: placebo and lactulose