The study will look at the liver metabolic function in patients with acute liver failure.
Conditions
Interventions
Product Name: 13C-labelled substrate 13C-methacetin
Pharmaceutical Form: Oral solution
INN or Proposed INN: methacetin
CAS Number: 72156-70-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Exalenz Bioscience Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Adult men or women (>18 years of age). 2. Acute Liver insult 3. No evidence of cirrhosis (unless clinical acute Wilsons) 4. INR > 1.8 5. Duration of illness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Patient with any chronic liver disease 2. Patient has severe congestive heart failure 3. Patient has severe pulmonary hypertension 4. Patient has chronic renal insufficiency with severe cardiac disease 5. Patient has previous surgical bypass surgery for morbid obesity 6. Patient has extensive small bowel resection 7. Patient with any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication 8. Patient is a recipient of any organ transplant 9. Patient with proven or suspected hepatocellular carcinoma 10. Patient is pregnant 11. Patient allergic to acetaminophen (such as Tylenol or any other related medications) 12. Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma 13. Patients with septic cholestasis 14. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs 15. Patients that are taking hepatotoxin drugs 16. Patient, based on the opinion of the investigator, should not be enrolled into this study 17. Patients unable or unwilling to sign informed consent 18. Patients that are participating in other clinical trials evaluating experimental treatments or procedures Exclusion Criteria (Day of MBT) 1. Patient has not fasted for 8 hours 2. Patient has smoked on the day of the test 3. Patient that has taken drugs that can interfere with methacetin metabolism : fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours 4. Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours 5. Patients that received general anesthesia or conscious sedation in the last 24 hours 6. Patient has consumed alcohol within the past 24 hours 7. Patients that still suffer from any previous clinical intervention (e.g. biopsy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to provide data on a novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. This, in the future may have an impact on decision making and clinical practice, allowing earlier listing for transplantation in the sickest group of patients, allowing greater chance of liver transplant and hence survival. In those patients who do not need liver transplantation it should allow earlier recognition of improvement and hence facilitate earlier discharge from hospital;Secondary Objective: An additional objective is safety evaluation through assessment of BreathID system (device and drug) related adverse events. Any adverse events will be reported according to GCP guidelines. ;Primary end point(s): The primary end-point of the study is to evaluate the ability of the MBT to predict earlier than current prognostic models and clinical parameters trends of improvement or deterioration based on breath test parameters alone or in conjunction with other clinical data compared to the clinical outcome (recovery, death, transplant). | — |
Countries
United Kingdom
Outcome results
None listed