Acute Liver FailureNCT02833064
Biomarkers in Liver Failure
An observational study of Acute Liver Failure and Acute Liver Injury, run by University of Edinburgh.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Acute Liver Failure, Acute Liver Injury, Acute on Chronic Hepatic Failure
- What is being tested?
- Non-contrast magnetic resonance imaging and Biological sampling
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2016to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Acute liver failure 2. Acute liver injury 3. Acute on chronic hepatic failure 4. Stable cirrhotics 5. Non-cirrhotic liver disease
Who may be able to join
- acute liver injury (newly deranged liver function tests (LFTs) and coagulopathy with International Normalized Ratio (INR) >1.5 in absence of chronic liver disease)
- acute liver failure ( as above, plus hepatic encephalopathy)
- acute on chronic liver failure (worsening of LFTS and development of at least 1 organ failure in patient with cirrhosis)
- stable cirrhosis
- non-cirrhotic liver disease
Who cannot join
- refusal of consent
- withdrawal of consent
About this study
Official title: Identification of Outcome Biomarkers in Patients With Liver Failure.
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.
Read the detailed 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.
- Being tested
- Non-contrast magnetic resonance imaging, Biological sampling
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast magnetic resonance imagingRadiation
Biological samplingOther
Blood, urine, stool and breath sampling and analysis
| Study group | Role | What they receive |
|---|---|---|
| Acute Liver Failure | * biological sampling
* MRI scanning for patients with paracetamol induced acute liver failure Receives: Radiation: Non-contrast magnetic resonance imaging; Other: Biological sampling | |
| Acute Liver Injury | - biological sampling Receives: Other: Biological sampling | |
| Acute on Chronic Hepatic Injury | - biological sampling Receives: Other: Biological sampling | |
| Stable Cirrhotics | - biological sampling Receives: Other: Biological sampling | |
| Non-cirrhotic liver disease | - biological sampling Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure.
Measured: 10 years
Secondary outcomes (1)
Identification of proteins involved in the pathogenesis of acute liver injury and acute liver failure
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start28 Nov 2016
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833064
- Sponsor's protocol ID
- AC16086
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2016
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Outcome Biomarkers in Patients With Liver Failure.
- ClinicalTrials.gov ID
- NCT02833064
- Acronym / sponsor ID
- AC16086
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acute Liver Failure | – | Radiation: Non-contrast magnetic resonance imaging, Other: Biological sampling* biological sampling * MRI scanning for patients with paracetamol induced acute liver failure |
| Acute Liver Injury | – | Other: Biological sampling- biological sampling |
| Acute on Chronic Hepatic Injury | – | Other: Biological sampling- biological sampling |
| Stable Cirrhotics | – | Other: Biological sampling- biological sampling |
| Non-cirrhotic liver disease | – | Other: Biological sampling- biological sampling |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Acute liver failure 2. Acute liver injury 3. Acute on chronic hepatic failure 4. Stable cirrhotics 5. Non-cirrhotic liver disease
Key inclusion criteria (5 listed)
- acute liver injury (newly deranged liver function tests (LFTs) and coagulopathy with International Normalized Ratio (INR) >1.5 in absence of chronic liver disease)
- acute liver failure ( as above, plus hepatic encephalopathy)
- acute on chronic liver failure (worsening of LFTS and development of at least 1 organ failure in patient with cirrhosis)
- stable cirrhosis
- non-cirrhotic liver disease
Key exclusion criteria (2 listed)
- refusal of consent
- withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contrast magnetic resonance imaging | Radiation | Acute Liver Failure |
| Biological samplingBlood, urine, stool and breath sampling and analysis | Other | Acute Liver Failure, Acute Liver Injury, Acute on Chronic Hepatic Injury, Non-cirrhotic liver disease, Stable Cirrhotics |
Primary outcome
Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure.
Time frame: 10 years
1 secondary outcome
Identification of proteins involved in the pathogenesis of acute liver injury and acute liver failure
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure and Acute Liver Injury, run by University of Edinburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.