Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
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|ClinicalTrials.gov Identifier: NCT00375011|
Recruitment Status : Terminated (Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz)
First Posted : September 12, 2006
Last Update Posted : February 16, 2012
The three objectives of this trial are:
- 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.
- 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.
- 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Use of the BreathID to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients With Cirrhosis in Need of Liver Transplantation|
|Study Start Date :||September 2008|
|Actual Study Completion Date :||October 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375011
|United States, Virginia|
|Department of Veteran Affairs|
|Richmond, Virginia, United States, 23249-0001|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23284|
|Hadassah Medical Organization|
|Principal Investigator:||Mitchell Shiffman, M.D.||Virginia Commonwealth University|
|Principal Investigator:||Douglas M Heuman, M.D.||Department of Veteran Affairs|
|Principal Investigator:||Maya Margalit, M.D.||Hadaassah Medical Organization|