Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.


Clinical Trial Description

Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic liver disease, regardless of etiology. During this procedure a core sample of liver is obtained and examined histologically for the presence of inflammation, fibrosis and other features characteristic of specific liver disorders.Although liver biopsy is the gold standard by which to assess liver disease severity the procedure has significant limitations. Liver biopsy is a costly, invasive procedure with risks for morbidity and mortality. In addition, liver biopsy and examination of liver histology is subject to sampling variation and the manner by which these findings are evaluated and reported by individual pathologists.

Because of these limitations several investigators have attempted to develop alternative methods by which to assess liver disease severity. One approach was the development of serum markers which can estimate liver fibrosis. Such tests were developed by analyzing a battery of serum liver chemistries and the platelet count. Unfortunately, the test cannot detect more subtle changes in liver fibrosis and does not provide any information regarding hepatic function in patients with established cirrhosis. The concept of a metabolic liver function test, which could be utilized to assess the liver function was first explored several decades ago (20). Such tests are performed by administering a compound either orally or intravenously. The compound is removed by the liver from the blood, metabolized and a metabolic product is released back into the blood and excreted in the urine, saliva or exhaled breath; or the metabolic product is excreted in bile. Measuring the amount of the administered product that remains in serum over time or the amount of metabolic product which is produced and/or the rate at which this product is excreted provides an accurate measure of hepatic metabolic function.

Breath testing utilizing 13C labeled substrates provides a safe, non-invasive means for measuring hepatic metabolism. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver. Ideally, the 13C-compound would be administered orally, rapidly absorbed, metabolized by the liver and 13CO2 would be measured in exhaled breath within 20-30 minutes. Hepatic metabolism of the compound would be assessed by measuring the ratio of 13C/12C in exhaled breath. The ability to detect, differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the Breath ID® collection system and analyzer unit. This portable device continuously senses exhaled breath and analyzes CO2 in real-time through a nasal cannula worn by the patient. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00244569
Study type Interventional
Source Virginia Commonwealth University
Contact
Status Completed
Phase Phase 3
Start date September 2005
Completion date April 2007

See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A