Brain Imaging in Patients With Chronic Liver Disease and Functional Impairment.

NCT00305591 | Completed

• 1 other identifier: 04/Q0406/161
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to disturbances in mood, behaviour and conscious levels. Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body. Patients with liver disease have previously been studied with MRI which has highlighted changes in the brain. This research aims to highlight some of the differences in the way that the brain functions in patients with liver disease. Using our new, more powerful MRI scanner, with more sophisticated techniques we hope that the novel combination of MRI techniques can objectively detect the presence of , and monitor HE. Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the brain, associated with low grade brain swelling and disturbances of the chemical balance within the brain, resulting in functional impairment, the presence of which MR imaging can detect with sufficient sensitivity to monitor the changes that may occur over time in response to treatment.

Conditions

Cirrhosis; Hepatic Encephalopathy

Keywords

magnetic resonance imaging; magnetic resonance spectroscopy; functional magnetic resonance imaging; cirrhosis; hepatic encephalopathy; l-ornithine l-aspartate

Outcome Measures

Primary Outcomes (1)

• All enrolled patients will be given 4 weeks of treatment. Both MRI and functional changes will be observed.

Interventions

l-ornithine l-aspartate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Biopsy-proven cirrhosis
• Clinically stable
• Able to give informed consent
• Fluent English (required for psychometric testing)

You may not qualify if:

• Ferro-magnetic implants
• Claustrophobia
• Weight \>120kg
• Significant renal impairment (Creatinine \>150 micromol/L)
• Poorly controlled Diabetes (particularly type I with microvascular complications)
• Alcohol: if alcoholic liver disease is the aetiology of their liver disease they should be abstinent. Otherwise less than 20g per day.

Sponsors & Collaborators

• Imperial College London: lead
• Royal College of Physicians: collaborator
• Paddington Charitable Estates Educational Fund: collaborator
• University of London: collaborator

Study Sites (1)

Imperial College London

Hammersmith, London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy

Interventions

ornithylaspartate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Simon D Taylor-Robinson, MBBS, FRCP

  Imperial College London & St Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: March 1, 2006
• Study Completion: October 1, 2007
• Last Updated: May 29, 2015

Record last verified: 2008-01

Locations

GB (1)