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

Completed

• Conditions: Cirrhosis; Liver Failure; Portal Hypertension

• Registration Number: NCT01774617
• Lead Sponsor: Guilherme Rezende

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Study Start: 2015-12
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• the study includes patients (80 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	6 months	Mortality within 6 months after evaluation, classifying as related or non-related to liver disease

Secondary Outcome Measures

Name	Time	Method
Chronic liver failure and portal hypertension complications	6 months	Complications: * gastroesophageal variceal bleeding; * worsening of hepatic encephalopathy; * decompensated ascites and spontaneous bacterial peritonitis; * hepatorenal syndrome

Trial Locations

Locations (1)

Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil