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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01434056
Enrollment
400
Registered
2011-09-14
Start date
2011-11-30
Completion date
2015-02-28
Last updated
2011-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Liver Disease, Hepatic Encephalopathy

Keywords

Liver disease, Hepatic encephalopathy, MELD, Liver transplantation

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.

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.

Interventions

None listed

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
MortalityThree months

Countries

Brazil

Contacts

Primary ContactEllison F Cardoso, MD, PhD
ellisonfc@einstein.br551121512487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026