Clinical Trials Directory

Trials / Unknown

UnknownNCT01434056

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

Status
Unknown
Phase
Study type
Observational
Enrollment
400 (estimated)
Sponsor
Hospital Israelita Albert Einstein · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2011-11-01
Primary completion
2014-11-01
Completion
2015-02-01
First posted
2011-09-14
Last updated
2011-09-14

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01434056. Inclusion in this directory is not an endorsement.