Clinical trial NCT01434056: Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Official title: Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Liver Disease
Hepatic Encephalopathy
Keywords: Liver disease
Hepatic encephalopathy
MELD
Liver transplantation
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients waiting for liver transplantation with chronic end stage liver disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Edson Amaro Junior, MD,PhD
role: STUDY_CHAIR
References:
citation: Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. doi: 10.1002/lt.20721.