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

Phase 4

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: placebo and lactulose; Drug: L-ornithine-L-aspartate and lactulose

• Registration Number: NCT00740142
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Study Start: 2008-09
• Primary Completion: 2010-08
• Study Completion: 2011-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo and lactulose	Oral lactulose
1	L-ornithine-L-aspartate and lactulose	Interventional arm: oral L-ornithine-L-aspartate and oral lactulose

Primary Outcome Measures

Name	Time	Method
To assess improvement of mental status of the patients	7 days

Secondary Outcome Measures

Name	Time	Method
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients	7 days

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand