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NCT01434056 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01434056
Other study ID # 1341-11
Secondary ID CEP1572
Status Not yet recruiting
Phase N/A
First received September 13, 2011
Last updated September 13, 2011
Start date November 2011
Est. completion date February 2015

Study information
Verified date September 2011
Source Hospital Israelita Albert Einstein
Contact Ellison F Cardoso, MD, PhD
Phone 551121512487
Email ellisonfc@einstein.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date February 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Hospital Israelita Albert Einstein São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Three months No
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