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

NCT00305591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-05-29

No results posted yet for this study

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

Interventions

DRUG

l-ornithine l-aspartate

Sponsors & Collaborators

  • Royal College of Physicians

    collaborator OTHER

  • Paddington Charitable Estates Educational Fund

    collaborator OTHER

  • University of London

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Simon D Taylor-Robinson, MBBS, FRCP · Imperial College London & St Mary's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Completion
2007-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00305591 on ClinicalTrials.gov