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

This study is not yet open for participant recruitment.
Verified September 2011 by Hospital Israelita Albert Einstein
Sponsor:
Information provided by (Responsible Party):
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01434056
First received: September 13, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 13, 2011
September 13, 2011
November 2011
November 2014   (final data collection date for primary outcome measure)
Mortality [ Time Frame: Three months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients waiting for liver transplantation with chronic end stage liver disease.

  • End Stage Liver Disease
  • Hepatic Encephalopathy
Not Provided
Liver transplantation waiting list
Patients waiting for liver transplantation with chronic end staged liver disease
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
February 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ellison F Cardoso, MD, PhD 551121512487 ellisonfc@einstein.br
Brazil
 
NCT01434056
1341-11, CEP1572
Yes
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein
Not Provided
Study Chair: Edson Amaro Junior, MD,PhD Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP