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

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ClinicalTrials.gov Identifier: NCT01434056
Recruitment Status : Unknown
Verified September 2011 by Ellison Fernando Cardoso, Hospital Israelita Albert Einstein.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein

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.

Condition or disease
End Stage Liver Disease Hepatic Encephalopathy

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.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
Study Start Date : November 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : February 2015


Group/Cohort
Liver transplantation waiting list
Patients waiting for liver transplantation with chronic end staged liver disease



Primary Outcome Measures :
  1. Mortality [ Time Frame: Three months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients waiting for liver transplantation with chronic end stage liver disease.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434056


Contacts
Contact: Ellison F Cardoso, MD, PhD 551121512487 ellisonfc@einstein.br

Locations
Brazil
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil, 05652901
Contact: Ellison F Cardoso, MD, PhD    551121512487    ellisonfc@einstein.br   
Principal Investigator: Ellison F Cardoso, MD, PhD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
Study Chair: Edson Amaro Junior, MD,PhD Hospital Israelita Albert Einstein

Publications:
Responsible Party: Ellison Fernando Cardoso, MD, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01434056     History of Changes
Other Study ID Numbers: 1341-11
CEP1572 ( Other Identifier: Ethical Committee Research )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Ellison Fernando Cardoso, Hospital Israelita Albert Einstein:
Liver disease
Hepatic encephalopathy
MELD
Liver transplantation

Additional relevant MeSH terms:
Liver Diseases
Brain Diseases
Hepatic Encephalopathy
End Stage Liver Disease
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Liver Extracts
Hematinics