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

Study Overview
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Brief Summary
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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.

Official Title
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Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation

Conditions
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Cirrhosis

Intervention / Treatment
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* Device: BreathID (Methacetin breath test)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Being considered for placement or already on the liver transplantation waiting list Cirrhosis caused by any cause of chronic liver disease. Age > 18 years Exclusion criteria: Known or suspected hepatocellular carcinoma Prior TIPS placement Severe congestive heart failure Severe pulmonary hypertension Uncontrolled diabetes mellitus (HBA1C >9.5%) Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. Previous surgical bypass surgery for morbid obesity (BMI >45) Extensive small bowel resection Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs Women who are pregnant Patients who are allergic to acetaminophen/ paracetamol or any other related medications Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. Patients that are taking hepatotoxin drugs Patient, based on the opinion of the investigator, should not be enrolled into this study Patient is unable or unwilling to sign informed consent. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laboratory assay<br> | Device: BreathID (Methacetin breath test)<br>* 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.<br>* Other names: BreathID (Exalenz Bioscience LTD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality From Liver Failure | Patient dies of liver-related causes within 1 year of study entry | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Transplantation | Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation | 1 year |