Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis

Overview

The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.

Full Title of Study: “Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

Interventions

  • Device: BreathID (Methacetin breath test)
    • 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.

Arms, Groups and Cohorts

  • Experimental: Laboratory assay

Clinical Trial Outcome Measures

Primary Measures

  • Mortality From Liver Failure
    • Time Frame: 1 year
    • Patient dies of liver-related causes within 1 year of study entry

Secondary Measures

  • Liver Transplantation
    • Time Frame: 1 year
    • Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation

Participating in This Clinical Trial

Inclusion Criteria

1. Being considered for placement or already on the liver transplantation waiting list 2. Cirrhosis caused by any cause of chronic liver disease. 3. Age > 18 years Exclusion criteria:

1. Known or suspected hepatocellular carcinoma 2. Prior TIPS placement 3. Severe congestive heart failure 4. Severe pulmonary hypertension 5. Uncontrolled diabetes mellitus (HBA1C >9.5%) 6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. 7. Previous surgical bypass surgery for morbid obesity (BMI >45) 8. Extensive small bowel resection 9. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs 10. Women who are pregnant 11. Patients who are allergic to acetaminophen/ paracetamol or any other related medications 12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. 13. Patients that are taking hepatotoxin drugs 14. Patient, based on the opinion of the investigator, should not be enrolled into this study 15. Patient is unable or unwilling to sign informed consent. 16. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • Meridian Bioscience, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard T Stravitz, MD, Principal Investigator, Virginia Commonwealth University

References

Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.

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