Breath test for patients with acute liver disease for early detection of the need for transplant or recovery

Not Applicable

Completed

• Conditions: Acute liver failure; Digestive System; Toxic liver disease

• Registration Number: ISRCTN45415158
• Lead Sponsor: Exalenz Bioscience Ltd (Israel)

Brief Summary

2012 conference abstract in: https://kclpure.kcl.ac.uk/portal/en/publications/use-of-an-online-at-the-point-of-care-13cmethacetin-breath-test-as-an-adjunct-tool-for-decision-making-in-patients-with-acute-liver-failure(2c878b71-95e1-40dd-8088-5b17f789d9c6).html (added 08/03/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-11
• Study Completion: 2011-10-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult men or women (greater than 18 years of age)
2. Acute liver insult
3. No evidence of cirrhosis (unless clinical acute Wilsons)
4. International Normalised Ratio (INR) greater than 1.8
5. Duration of illness less than 12 or 24 weeks (to be determined [TBD])

Exclusion Criteria

1. Any chronic liver disease
2. Severe congestive heart failure
3. Severe pulmonary hypertension
4. Chronic renal insufficiency with severe cardiac disease
5. Previous surgical bypass surgery for morbid obesity
6. Extensive small bowel resection
7. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
8. Recipient of any organ transplant
9. Proven or suspected hepatocellular carcinoma
10. Pregnant
11. Allergic to paracetamol (such as Tylenol® or any other related medications)
12. History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
13. Septic cholestasis
14. Currently receiving total parenteral nutrition if they have contraindications to oral drugs
15. Taking hepatotoxin drugs
16. Hypersensitivity to paracetamol
17. Based on the opinion of the investigator, patient should not be enrolled into this study
18. Unable or unwilling to sign informed consent
19. Participating in other clinical trials evaluating experimental treatments or procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified