Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

• Conditions: End Stage Liver Disease; Hepatic Encephalopathy

• Registration Number: NCT01434056
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation.

Detailed Description

The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction.

Adding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation.

We will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation.

Study Timeline

• Status Verified: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Last Update Submitted: 2011-09-13
• Study First Posted: 2011-09-14
• Last Update Posted: 2011-09-14
• Study Start: 2011-11
• Primary Completion: 2014-11
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Man or woman over 18 years old
• Listed in liver transplantation waiting line
• Patient able and willing to participate in the evaluations of this study

Exclusion Criteria

• Acute liver failure
• Serious structural brain anomalies
• Condition or situation in which, in the opinion of the investigator, put the patient at significant risk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Three months

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil