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

NCT00375011 | Terminated

• 1 other identifier: BID CIRR
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief Summary

The three objectives of this trial are:

1. 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. 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. 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.

Conditions

Cirrhosis

Keywords

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis determined by liver histology or clinical findings

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)
• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead
• Virginia Commonwealth University: collaborator
• US Department of Veterans Affairs: collaborator
• Hadassah Medical Organization: collaborator

Study Sites (3)

Department of Veteran Affairs

Richmond, Virginia, 23249-0001, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (9)

• Hoyert DL, Kung HC, Smith BL. Deaths: preliminary data for 2003. Natl Vital Stat Rep. 2005 Feb 28;53(15):1-48.

  PMID: 15779680 BACKGROUND

• Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.

  PMID: 16702586 BACKGROUND

• Said A, Williams J, Holden J, Remington P, Gangnon R, Musat A, Lucey MR. Model for end stage liver disease score predicts mortality across a broad spectrum of liver disease. J Hepatol. 2004 Jun;40(6):897-903. doi: 10.1016/j.jhep.2004.02.010.

  PMID: 15158328 BACKGROUND

• Bambha K, Kim WR, Kremers WK, Therneau TM, Kamath PS, Wiesner R, Rosen CB, Thostenson J, Benson JT, Dickson ER. Predicting survival among patients listed for liver transplantation: an assessment of serial MELD measurements. Am J Transplant. 2004 Nov;4(11):1798-804. doi: 10.1111/j.1600-6143.2004.00550.x.

  PMID: 15476479 BACKGROUND

• Sanyal AJ, Banas C, Sargeant C, Luketic VA, Sterling RK, Stravitz RT, Shiffman ML, Heuman D, Coterrell A, Fisher RA, Contos MJ, Mills AS. Similarities and differences in outcomes of cirrhosis due to nonalcoholic steatohepatitis and hepatitis C. Hepatology. 2006 Apr;43(4):682-9. doi: 10.1002/hep.21103.

  PMID: 16502396 BACKGROUND

• Shiffman ML, Saab S, Feng S, Abecassis MI, Tzakis AG, Goodrich NP, Schaubel DE. Liver and intestine transplantation in the United States, 1995-2004. Am J Transplant. 2006;6(5 Pt 2):1170-87. doi: 10.1111/j.1600-6143.2006.01273.x.

  PMID: 16613594 BACKGROUND

• Festi D, Capodicasa S, Vestito A, Mazzella G, Roda E, Vitacolonna E, Petrolati A, Angelico M, Colecchia A. Breath tests with stable isotopes: have they a role in liver transplantation? Eur Rev Med Pharmacol Sci. 2004 Jan-Feb;8(1):55-8.

  PMID: 15209156 BACKGROUND

• Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.

  PMID: 15679768 BACKGROUND

• Festi D, Capodicasa S, Sandri L, Colaiocco-Ferrante L, Staniscia T, Vitacolonna E, Vestito A, Simoni P, Mazzella G, Portincasa P, Roda E, Colecchia A. Measurement of hepatic functional mass by means of 13C-methacetin and 13C-phenylalanine breath tests in chronic liver disease: comparison with Child-Pugh score and serum bile acid levels. World J Gastroenterol. 2005 Jan 7;11(1):142-8. doi: 10.3748/wjg.v11.i1.142.

  PMID: 15609414 BACKGROUND

Related Links

• BreathID (device used for study) website

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular; Hepatitis C

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2006
• First Posted: September 12, 2006
• Study Start: September 1, 2008
• Study Completion: October 1, 2011
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

US (2); IL (1)