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Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List

This study is currently recruiting participants.
Verified February 2013 by Federal University of Rio de Janeiro
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Guilherme Rezende, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01774617
First received: January 22, 2013
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

It is a cohort to evaluate the power of different diagnostic tests in predicting the prognosis of patients with severe liver disease.

Patients with decompensated liver cirrhosis on the waiting list for liver transplantation will be evaluated with comparison of different diagnostic tests according to the MELD score (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium), indocyanine green clearance test, hepatic venous pressure gradient and transient elastography. All patients will be submitted to all the tests and prospectively followed for 6 months, to establish mortality and complications related to liver disease in order to define the value of each method to predict outcomes.


Condition Intervention
Liver Transplantation
Cirrhosis
 Procedure: Comparison of different diagnostic tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparative Analysis of Indocyanine Green Clearance Test, Model for End Stage Liver Disease(MELD)Score, MELD-Na Score, Transient Elastography and Hepatic Venous Pressure Gradient to Evaluate Prognosis of Patients on Liver Transplant Waiting List

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mortality within 6 months after evaluation, classifying as related or non-related to liver disease


Secondary Outcome Measures:
  • Chronic liver failure and portal hypertension complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Complications:

    • gastroesophageal variceal bleeding
    • worsening of hepatic encephalopathy
    • decompensated ascites and spontaneous bacterial peritonitis
    • hepatorenal syndrome


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
whole sample Procedure: Comparison of different diagnostic tests
Other Name: Hepatic venous pressure gradient measurement

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the study will include patients (100 patients)
  • were male and female
  • aged between 18 and 69 years with chronic liver disease
  • with MELD inclusion greater than or equal to 14 to 30

Exclusion Criteria:

  • they have been transplanted
  • Have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed
  • MELD scores greater than 30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774617

Contacts
Contact: Guilherme Rezende, PhD 552199976292 g.rezende@superig.com.br
Contact: Alexandre Cerqueira, MD 552188890155 cerqueira@hucff.ufrj.br

Locations
Brazil
Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro Recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Contact: Alexandre Cerqueira, MD     55-21-88890155     cerqueira@hucff.ufrj.br    
Contact: Guilherme FM Rezende, MD PhD     55-21-99976292     g.rezende@superig.com.br    
Sub-Investigator: Alexandre Cerqueira, MD            
Sponsors and Collaborators
Guilherme Rezende
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Study Chair: Guilherme FM Rezende, MD PhD Federal University of Rio de Janeiro
  More Information

No publications provided

Responsible Party: Guilherme Rezende, Associate Professor, MD PhD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01774617     History of Changes
Other Study ID Numbers: HHL/UFRJ-04, CAAE 06343212.8.0000.5257
Study First Received: January 22, 2013
Last Updated: February 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:
portal hypertension
elastography
Hepatic venous pressure gradient measurement

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
End Stage Liver Disease
Liver Diseases
 Digestive System Diseases
Pathologic Processes
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013