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

Cirrhosis Clinical Trial

Official title:

Comparative Analysis of Indocyanine Green Clearance Test, MELD Score, MELD-Na Score, Transient Elastography and Hepatic Venous Pressure Gradient to Evaluate Prognosis of Patients on Liver Transplant Waiting List

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774617
• Other study ID #: HHL/UFRJ-04
• Secondary ID: CAAE 06343212.8.
• Status: Completed
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: October 2020
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension
• Hypertension, Portal
• Liver Failure
• Portal Hypertension

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Guilherme Rezende	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Mortality within 6 months after evaluation, classifying as related or non-related to liver disease	6 months
Secondary	Chronic liver failure and portal hypertension complications	Complications: gastroesophageal variceal bleeding; worsening of hepatic encephalopathy; decompensated ascites and spontaneous bacterial peritonitis; hepatorenal syndrome	6 months