ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborators:
Virginia Commonwealth University
VA Office of Research and Development
Hadassah Medical Organization
Information provided by:
Exalenz Bioscience LTD.

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 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.


Condition or disease
Cirrhosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhosis determined by liver histology or clinical findings
Criteria

Inclusion Criteria:

  1. Cirrhosis determined by liver histology or clinical findings.
  2. Age > 18 years

Exclusion Criteria:

  1. Known or suspected HCC
  2. Hepato-pulmonary syndrome
  3. Hepatorenal syndrome (creatinine > 2.5 mg/dl)
  4. Refractory ascites (More than 1 paracentesis within the preceding 3 months of enrollment. A single paracentesis performed for diagnostic purposes is not an exclusion)
  5. Hyponatremia
  6. Prior TIPS placement
  7. Prior episode of variceal hemorrhage
  8. MELD score >25
  9. Any patient whose expected time to liver transplantation is less than 3 months

Information from the National Library of Medicine

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


Locations
United States, Virginia
Department of Veteran Affairs
Richmond, Virginia, United States, 23249-0001
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Exalenz Bioscience LTD.
Virginia Commonwealth University
VA Office of Research and Development
Hadassah Medical Organization
Investigators
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

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00375011     History of Changes
Other Study ID Numbers: BID CIRR
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2010

Keywords provided by Exalenz Bioscience LTD.:
MELD-Model of End Stage Liver Disease score
CTP-Child-Turcotte-Pugh score
MEGX-monoethylglycinexylidide-resultant of metabolism of lidocaine
HCC-Hepatocellular carcinoma
HCV-Hepatitis C virus
NASH-Non-alcoholic Steatohepatitis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases