Acute liver failure Digestive System Toxic liver disease
Conditions
Interventions
This is a study of the MBT to assess liver function in patients with acute and/or chronic liver injury. All patients with acute liver disease meeting the inclusion/exclusion criteria will be accepted
these may be performed in the course of a 21-day period, including days 0, 2, 4, 6, 10, 14, and 21.
Sponsors
Exalenz Bioscience Ltd (Israel)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop a model to predict deterioration of liver disease, which incorporates measurements from the MBT along with other potential variables. Tests will be performed in the course of a 21-day period or discontinued when the patient is discharged from hospital or if transplantation is undertaken or the patients' ongoing care is deemed futile and palliative care is being undertaken. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation through assessment of BreathID system (device and drug) related adverse events. Tests will be performed in the course of a 21-day period or discontinued when the patient is discharged from hospital or if transplantation is undertaken or the patients' ongoing care is deemed futile and palliative care is being undertaken. | — |
Countries
Israel, United Kingdom, United States of America
Outcome results
None listed