Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation

May 9, 2016 updated by: Sara Abdelhakam, Ain Shams University
This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.

Description

Inclusion Criteria:

  • Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation

Exclusion Criteria:

  • Overt hepatic encephalopathy.
  • Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging.
  • Regular use of psychotropic drugs, such as benzodiazepines.
  • Known major psychiatric disorder.
  • Less than 6 months of complete alcohol abstinence.
  • Post-transplant toxic levels of immunosuppressive drugs.
  • Patients unable to perform the tests (Illiterate or upper limb motor handicaps).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Group
Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.
Procedure: Liver transplantation
Control Group
Twenty age-matched healthy persons. They were similar to the patient group in respect to the number of education years, sex, and handedness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of Psychometric tests.
Time Frame: 6 months following liver transplantation.
6 months following liver transplantation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of liver functions and MELD score following liver transplantation.
Time Frame: 6 months following liver transplantation.
6 months following liver transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 7, 2016

First Submitted That Met QC Criteria

May 7, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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