Status:
COMPLETED
Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy
Lead Sponsor:
Aga Khan University
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.
Detailed Description
There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrate...
Eligibility Criteria
Inclusion
- Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis,
- Patients \>14 years, with HE grades 1 to 4 according to West Haven Criteria,
- Hyperammonemia (fasting venous blood ammonia level \>60 µmol/l), and
- Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none.
Exclusion
- hepatocellular carcinoma,
- severe septicemia,
- active gastrointestinal bleeding,
- hepatorenal syndrome,
- acute superimposed liver injury,
- advanced cardiac or pulmonary disease and end stage renal failure,
- patients with minimal HE
- patients taking sedatives, antidepressants, or benzodiazepines and
- patients with chronic HE on metronidazole or lactulose prior to admission.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00433368
Start Date
October 1 2003
End Date
September 1 2004
Last Update
February 9 2007
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800