Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 operation. Left untreated it may lead to deep coma. The cause is not fully understood but is though to be related to the inability of a damaged liver to filter out toxins such as ammonia in the blood, which then accumulate within the brain and result in altered function and swelling within certain brain cells,astrocytes. These patients also suffer from muscle loss, which is associated with a poor outcome. L-ornithine L-aspartate(LOLA) is a licensed drug in Germany and has been shown to promote ammonia elimination from the body in the form of urea. Some experimental studies have suggested that LOLA also potentially attenuates muscle loss by incorporating ammonia into muscle in the form of glutamine. The aim of this study is to determine cognitive and nutritional effects of 12 weeks of LOLA administration and its effect on brain muscle structure and function in patients with cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: N-Methylaspartate

Criteria

Inclusion Criteria:

• Ambulant patients of any Child-Pugh stage cirrhosi and PHEs defined MHe or grade 1 encephalopathy

Exclusion Criteria:

• 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.