Status:
COMPLETED
Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate
Lead Sponsor:
Imperial College London
Conditions:
Hepatic Encephalopathy
Minimal Hepatic Encephalopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Patients with cirrhosis of the liver may suffer from a condition called hepatic encephalopathy which in its mildest form as mental slowing and impaired reaction times in driving and machinery operatio...
Detailed Description
This is a Phase IV randomised double blind, placebo controlled study. Thirty four patients with cirrhosis will be studied with psychometric tests, clinical brain magnetic resonance imaging(MRI),includ...
Eligibility Criteria
Inclusion
- Ambulant patients of any Child-Pugh stage cirrhosi and PHEs defined MHe or grade 1 encephalopathy
Exclusion
- Previous episodes of overt HE without a clear precipitant
- Recurrent excessive alcohol consumption (abstinence for those with alcoholic liver disease otherwise less than 28 units per week)
- Severe coagulopathy (INR\>2, platelets \<60 000/uL, Fibrinogen \<1mg/dl)
- known myopathy or myositis, taruma to lower extremities within 3 months)
- Renal dysfunction with a serum creatinine\>3mg/dl (265micromol/L)
- Ferromagnetic implants
- Recent intestinal haemorrhage within 1 month
- Claustrophobia
- Weight \>120kg
- Major psychoactive medication such as antipsychotic agents
- Known cerebrovascular disease or pre-existing neurological conditions
- Age less than 18 or greater than 65.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01847651
Start Date
August 1 2013
End Date
June 1 2015
Last Update
October 22 2015
Active Locations (1)
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1
Liver unit St Mary's Hospital, 10th floor QEQM Wing, South Wharf Road
London, London, United Kingdom, W2 1NY