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

Phase 3

Completed

• Conditions: Cirrhosis
• Interventions: Device: BreathID (Methacetin breath test)

• Registration Number: NCT01157845
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-01-17
• Results First Submitted QC: 2014-01-17
• Results First Posted: 2014-03-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-29
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laboratory assay	BreathID (Methacetin breath test)	-

Primary Outcome Measures

Name	Time	Method
Mortality From Liver Failure	1 year	Patient dies of liver-related causes within 1 year of study entry

Secondary Outcome Measures

Name	Time	Method
Liver Transplantation	1 year	Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation

Trial Locations

Locations (4)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States