Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02833064 |
| Other study ID # |
AC16086 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 28, 2016 |
| Est. completion date |
November 30, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the
latter often associated with a poor outcome. To improve outcomes for these patients,
clinicians need to develop a clearer understanding of the pathophysiology of this condition.
Biomarkers and novel imaging techniques are vital to investigating and understanding the
pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be
eligible to take part in the study. The study will involve collection of biological samples
(blood, urine, stool and breath) from included patients once daily for up to 7 days. For
patients undergoing liver transplantation, a small sample of explanted (removed) liver tissue
will be obtained. A small subgroup of patients with paracetamol induced acute liver failure
will be eligible to be included in a pilot MRI (magnetic resonance imaging) study, which will
involve two MRI scans during the first 7 days of their admission. All patients will be
recruited from the Royal Infirmary of Edinburgh.
Description:
For inpatients, the investigators wish to collect biological samples from each patient once
daily for the first seven days of their admission. 25mls of blood will be taken daily for
research purposes, at the same time at routine clinical samples to reduce discomfort from
additional venepuncture. One urine sample will be taken daily (which can be taken from a
catheter if the patient has a catheter in place), and a sample of stool if the patient moves
their bowels. The investigators wish to collect breath for analysis, at one point during the
first seven days of admission. Breath analysis requires the patients to be fasted for four
hours (with the exception of water) prior to the test. If the patient undergoes liver
transplantation during their admission, a small sample of explanted liver tissue will be
obtained for later analysis.
For outpatients (acute liver injury, stable cirrhotics, non-cirrhotic liver disease), the
investigators will ask them to attend the ward or the outpatient department for collection of
biological samples. The investigators will take 25 mls of blood as above, along with a urine
and stool sample if they are able to provide this at their first attendance. Breath analysis
will also be undertaken during this visit to the hospital, after a 4 hour fast (with the
exception of water). Outpatients will then be asked to return one month later, when further
blood (25mls), urine and stool samples will be collected.
As a pilot study, the investigators wish to perform MRI scanning on a subset of 10 patients
with paracetamol induced acute liver failure. Paracetamol induced acute liver failure is
associated with a particularly rapid course, characterised by hepatic encephalopathy and
renal impairment. In view of the potential for renal impairment, intravenous contrast will
not be used for these scans, but alternative techniques employed such as artertial spin
labelling.
The participant does not need to consent to each individual part of the study to be able to
take part.
