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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-07-31

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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Laboratory assay

Group Type EXPERIMENTAL

BreathID (Methacetin breath test)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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BreathID (Exalenz Bioscience LTD)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No