Phase 3
Completed N=165
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
Source: ClinicalTrials.gov NCT01157845 ↗Enrolled (actual)
165
Serious AEs
64.9%
Results posted
Mar 2014
Primary outcomePrimary: Mortality From Liver Failure — 11 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality From Liver Failure |
11 | — |
| SECONDARY Liver Transplantation |
34 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01157845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.