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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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
End Stage Liver Disease
Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • Mortality [ Time Frame: Three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
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)
Groups/Cohorts
Liver transplantation waiting list
Patients waiting for liver transplantation with chronic end staged liver disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: September 13, 2011
Last Updated: September 13, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Israelita Albert Einstein:
Liver disease
Hepatic encephalopathy
MELD
Liver transplantation

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

ClinicalTrials.gov processed this record on October 20, 2014