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ISRCTN
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ISRCTN45415158
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ClinicalTrials.gov identifier
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Public title
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Breath test for patients with acute liver disease for early detection of the need for transplant or recovery
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Scientific title
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Breath test for patients with acute liver disease for early detection of the need for transplant or recovery: a multicentre non-randomised study
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Acronym
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BTALD (Breath Test in Acute Liver Disease)
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Serial number at source
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ALF-BID-1108
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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South East Research Ethics Committee approved on the 21st October 2009 (ref: 09/H1102/62)
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Study design
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Multicentre non-randomised study
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Countries of recruitment
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Israel, United Kingdom, United States of America
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Disease/condition/study domain
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Acute liver failure
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Participants - inclusion criteria
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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])
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Participants - exclusion criteria
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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
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Anticipated start date
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02/11/2009
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Anticipated end date
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30/10/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Exalenz Bioscience Ltd (Israel)
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Trial website
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Publications
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Contact name
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Dr
Julia
Wendon
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Address
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King's College Hospital
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 9RS
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Country
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United Kingdom
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Sponsor
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Exalenz Bioscience Ltd (Israel)
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Address
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c/o Steven Eitan
4 Maayan
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City/town
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Modi'in
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Zip/Postcode
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71700
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Country
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Israel
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Date applied
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27/10/2009
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Last edited
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11/02/2010
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Date ISRCTN assigned
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11/02/2010
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