Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Recruitment status was Not yet recruiting
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.
End Stage Liver Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging|
- Mortality [ Time Frame: Three months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Liver transplantation waiting list
Patients waiting for liver transplantation with chronic end staged liver disease
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434056
|Contact: Ellison F Cardoso, MD, PhDfirstname.lastname@example.org|
|Hospital Israelita Albert Einstein||Not yet recruiting|
|São Paulo, Brazil, 05652901|
|Contact: Ellison F Cardoso, MD, PhD 551121512487 email@example.com|
|Principal Investigator: Ellison F Cardoso, MD, PhD|
|Study Chair:||Edson Amaro Junior, MD,PhD||Hospital Israelita Albert Einstein|