Quantitative Liver Function Tests Using Cholates

As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for their outcomes. The traditional assessment of the liver patient has been limited to imaging, static measures of "liver function tests" and liver biopsy. This protocol is designed to increase the spectrum of tests in the evaluation of the patient with end stage liver disease.

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Liver Disease
• Intervention / Treatment: Drug: Cholates

Detailed Description

This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2

This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient [HVPG] procedure.)

The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease patients
• Age: 18 yr to 80 yr
• Patients or Legal Authorized Representative (LAR) must provide written consent and be willing and able to adhere to study requirements
• Stage 3-4 fibrosis by METAVIR score or clinical evidence of advanced fibrosis (End-stage liver disease patients only)

Exclusion Criteria:

• Hepatic encephalopathy Grade 3 or 4
• Pregnancy or intent to become pregnant
• Subjects with inability to provide consent for one's self
• Subjects with a life expectancy < 1 year
• Subjects who have participated in an investigational drug study within the past 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cholates Compound	Drug: Cholates; Cholates is given intravenously (IV push) and by mouth, once per study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the effectiveness and accuracy of quantitative liver function testing using oral and IV cholate in patients with end-stage liver disease OR in patients who donate a portion of their liver	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare presence and extent of the cholate clearances	One year

Other Outcome Measures

Outcome Measure	Time Frame
Annual tests to measure changes in liver function	one year

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: James Trotter, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimated): July 24, 2013

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cirrhosis; end stage liver disease; living liver donor; liver function tests
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease; Gastrointestinal Agents; Cholic Acids
• Other Study ID Numbers: 011-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO