Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
Stopped early
Conditions studied: Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT00375011
- Run by
- Meridian Bioscience, Inc.
- People needed
- 200
- Starts
- 2008-09-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2022-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cirrhosis determined by liver histology or clinical findings.
- Age > 18 years
You may not qualify if…
- 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
Where it is running
- Department of Veteran Affairs — Richmond, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Hadassah Medical Organization — Jerusalem, Israel
Full record on ClinicalTrials.gov
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