Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
Patients waiting for liver transplantation with chronic end stage liver disease.
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| Contact: Ellison F Cardoso, MD, PhD | 551121512487 | ellisonfc@einstein.br |
| 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 | |
| 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:
|
Hepatic Encephalopathy Liver Diseases Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes End Stage Liver Disease Liver Failure Hepatic Insufficiency Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Metabolic Diseases Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 21, 2013