Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01435421
Protocol/serial number
ALF-BID-1108
Study information
Scientific title
Breath test for patients with acute liver disease for early detection of the need for transplant or recovery: a multicentre non-randomised study
Acronym
BTALD (Breath Test in Acute Liver Disease)
Study hypothesis
This study is designed to develop a model to predict deterioration of liver disease, which incorporates measurements from the 13C-Methacetin Breath Test (MBT) along with other potential variables. The data collected will be used to develop a prediction model using data-mining methodology (linear and non-linear regression models, binary trees, neural networks, etc.,). The predictive models may include measurements from the MBT and blood test results as single measurements or as a trend over time. The model that will be developed will attempt to predict the disease deterioration versus recovery accurately, at an earlier time point than the standard procedure. A threshold will then be determined based on adequate sensitivity and specificity levels.
Ethics approval
South East Research Ethics Committee approved on the 21/10/2009, ref: 09/H1102/62
Study design
Multicentre non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute liver failure
Intervention
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 to this study. Patients will perform up to 7 tests; these may be performed in the course of a 21-day period, including days 0, 2, 4, 6, 10, 14, and 21.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
02/11/2009
Overall trial end date
30/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
02/11/2009
Recruitment end date
30/10/2011
Locations
Countries of recruitment
Israel, United Kingdom, United States of America
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Funders
Funder type
Industry
Funder name
Exalenz Bioscience Ltd (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list