Clinical trial NCT01157845: Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
Official title: Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cirrhosis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Meridian Bioscience, Inc.
First posted: 2010-07-07
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality From Liver Failure
timeFrame: 1 year
Secondary outcomes:
measure: Liver Transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Virginia Commonwealth University
name: Richard T Stravitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.