Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Encephalopathy
Intervention: L-ornithine-L-aspartate and lactulose (Drug); placebo and lactulose (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Siwaporn Chainuvati, MD, Principal Investigator, Affiliation: Mahidol University
Overall contact:
Siwaporn Chainuvati, MD, Phone: (662) 4197281, Email: siswf@mahidol.ac.th
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
Clinical Details
Official title: Efficacy of Combined Oral L-Ornithine-L-Aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To assess improvement of mental status of the patients
Secondary outcome: To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Siwaporn Chainuvati, MD, Phone: (662) 4197281, Email: siswf@mahidol.ac.th
Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand; Recruiting
Siwaporn Chainuvati, MD, Phone: (662)4197281, Email: siswf@mahidol.ac.th
Supot Nimanong, MD, Sub-Investigator
Siwaporn Chainuvati, MD, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: June 25, 2009
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