Prediction of Mortality in Patients Waiting for Liver Tra... | NCT01434056

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

NCT01434056

Sponsor

Hospital Israelita Albert Einstein

Status

Unknown status

Last Update Posted

Sep 14, 2011Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

End Stage Liver Disease
Hepatic Encephalopathy

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CEP1572	Other Identifier	Ethical Committee Research

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2014Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Sep 13, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 14, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellison Fernando Cardoso, MD, PhD, Hospital Israelita Albert EinsteinPrincipal Investigator

Lead Sponsor

Hospital Israelita Albert EinsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplantation waiting list		Patients waiting for liver transplantation with chronic end staged liver disease

Interventions

Not provided

Measure	Description	Time Frame
Mortality		Three months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ellison F Cardoso, MD, PhD	Contact	551121512487		ellisonfc@einstein.br

Overall Officials

Name	Affiliation	Role
Edson Amaro Junior, MD,PhD	Hospital Israelita Albert Einstein	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Israelita Albert Einstein		São Paulo	São Paulo	05652901	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16498643	Background	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. doi: 10.1002/lt.20721.

ID	Term
D058625	End Stage Liver Disease
D006501	Hepatic Encephalopathy
D008107	Liver Diseases

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D004066	Digestive System Diseases
D001928	Brain Diseases, Metabolic