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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 3

Conditions: Cirrhosis

Treatments: Device: BreathID (Methacetin breath test)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01157845

VirginiaCU HM12041

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Laboratory assay

Experimental group

Treatment:

Device: BreathID (Methacetin breath test)