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 number	NCT01435421
Secondary identifying numbers	ALF-BID-1108

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

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Study design	Multicentre non-randomised study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	02/11/2009
Completion date	30/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
Israel
United Kingdom
United States of America

Study participating centre

King's College Hospital

London
SE5 9RS
United Kingdom

Sponsor information

Exalenz Bioscience Ltd (Israel)
Industry

c/o Steven Eitan
4 Maayan
Modi'in
71700
Israel

"ROR"	https://ror.org/04e29rd57

Funders

Funder type

Industry

Exalenz Bioscience Ltd (Israel)

No information available

Results and Publications

Intention to publish date	31/03/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

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.