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Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

NCT00375011 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-12-20

No results posted yet for this study

Summary

The three objectives of this trial are:

1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis.
2. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk to develop complications of cirrhosis.
3. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk for liver related mortality.

The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and that thresholds can be established that will help predict risk of complications of cirrhosis and mortality.

Conditions

  • Cirrhosis

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • Hadassah Medical Organization

    collaborator OTHER

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Mitchell Shiffman, M.D. · Virginia Commonwealth University

  • Douglas M Heuman, M.D. · Department of Veteran Affairs

  • Maya Margalit, M.D. · Hadaassah Medical Organization

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Completion
2011-10-31

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375011 on ClinicalTrials.gov