Breath test for patients with acute liver disease for early detection of the need for transplant or recovery
| ISRCTN | ISRCTN45415158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45415158 |
| ClinicalTrials.gov (NCT) | NCT01435421 |
| Protocol serial number | ALF-BID-1108 |
| Sponsor | Exalenz Bioscience Ltd (Israel) |
| Funder | Exalenz Bioscience Ltd (Israel) |
- Submission date
- 27/10/2009
- Registration date
- 11/02/2010
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julia Wendon
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | BTALD (Breath Test in Acute Liver Disease) |
| Study objectives | 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(s) | South East Research Ethics Committee approved on the 21/10/2009, ref: 09/H1102/62 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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]) |
| Key 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 |
| Date of first enrolment | 02/11/2009 |
| Date of final enrolment | 30/10/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
- Israel
- United States of America
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | conference abstract | 01/10/2012 | 08/03/2019 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/04/2019: Internal review.
08/03/2019: Publication reference added.
08/04/2016: No publications found, verifying study status with principal investigator.
