Status:
TERMINATED
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Virginia Commonwealth University
US Department of Veterans Affairs
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Brief 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 cirr...
Detailed Description
BACKGROUND: 1. Mortality in patients with chronic liver disease and cirrhosis: Chronic liver disease is the 9th most common cause of death in the United States. Unfortunately, mortality secondary...
Eligibility Criteria
Inclusion
- Cirrhosis determined by liver histology or clinical findings.
- Age \> 18 years
Exclusion
- Known or suspected HCC
- Hepato-pulmonary syndrome
- Hepatorenal syndrome (creatinine \> 2.5 mg/dl)
- Refractory ascites (More than 1 paracentesis within the preceding 3 months of enrollment. A single paracentesis performed for diagnostic purposes is not an exclusion)
- Hyponatremia
- Prior TIPS placement
- Prior episode of variceal hemorrhage
- MELD score \>25
- Any patient whose expected time to liver transplantation is less than 3 months
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00375011
Start Date
September 1 2008
End Date
October 1 2011
Last Update
December 20 2022
Active Locations (3)
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1
Department of Veteran Affairs
Richmond, Virginia, United States, 23249-0001
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
3
Hadassah Medical Organization
Jerusalem, Israel