Acute Liver FailureMAP-ALFNCT07131969
Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis
An observational study of Acute Liver Failure and Sepsis, run by University of Cambridge at 7 sites in United Kingdom.
Trial summary
Context Acute liver failure (ALF) is a life-threatening condition that occurs on the background of a healthy liver. The most common cause of acute liver failure in the UK is paracetamol overdose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Liver Failure, Sepsis
- What is being tested?
- blood draw
- How many people
- 100 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Sep 2025to Sep 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute liver failure due to acetaminophen overdose OR sepsis who are admitted to ICU
Who may be able to join
- acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU
- all cause sepsis admitted to ICU
Who cannot join
- age <16y
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites
University Hospitals Birmingham
Birmingham
Addenbrooke's Hospital
Cambridge
Andrew Conway-Morris
Royal Infirmary of Edinburgh
Edinburgh
Leeds General Infirmary
Leeds
Andrew Ratcliffe
Kings College Hospital
London
Mark McPhail
Royal Free Hospital
London
Amy Sangam
Freeman Hospital
Newcastle
Iain McCullagh
About this study
Official title: Transcriptional Analysis of Mechanisms and Predictors in Acute Liver Failure and Sepsis
Context Acute liver failure (ALF) is a life-threatening condition that occurs on the background of a healthy liver. The most common cause of acute liver failure in the UK is paracetamol overdose. Acute liver failure results from liver damage and activation of the body's inflammatory defences with subsequent damage to other organs including kidneys, lungs and heart. This often requires life support in an intensive care unit before liver transplantation (LT), the only currently available and effective rescue treatment for acute liver failure.
Challenge Patient factors and organ availability limit who can benefit from liver transplant. At present there are no effective alternative therapies for patients who do not get a liver transplant, and survival rates in these situations are poor. The underlying mechanisms of inflammation are poorly understood, thus therapies are limited.
Read more
Aim The investigators research aims to understand the mechanisms that underpin the inflammation seen in acute liver failure by studying the inflammatory cells in the blood and examining their cellular programmes. This will allow the investigators to identify pathways that are activated and understand how the liver and blood interact to spread inflammation around the body. The investigators aim to identify targets for disease-modifying therapies to avert the need for liver transplant.
Importance Understanding how the body responds to acute liver failure, and whether there are different patterns of inflammatory response, will enable trials of immune-modulating drugs to prevent the need for liver transplantation or prolong the time a patient can wait for an organ. This has the potential to help improve organ availability for other patients and save lives in acute liver failure.
- Conditions
- Acute Liver Failure, Sepsis
- Being tested
- blood draw
- Keywords
- acute liver failure, sepsis, transcriptional analysis, predictors, paracetamol overdose, acetaminophen overdose
- Medical subject headings
- Liver Failure, Acute, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
Venous blood sampling into Tempus tube for RNA-sequencing
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute liver failure or sepsis | Not described Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: From enrolment until at least 1-year
Secondary outcomes (3)
Transplant free survival
30-day and 1-year survival without transplant
Measured: From enrolment to at least one year
Length of stay - ICU and hospital
Number of days stayed in ICU and in-hospital
Measured: From enrolment
Transplant free mortality
Death without transplant
Measured: From enrolment until death (at least until 1year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Dhupal Patel, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131969
- Sponsor's protocol ID
- A097365
- Acronym
- MAP-ALF
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 26 Aug 2025
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptional Analysis of Mechanisms and Predictors in Acute Liver Failure and Sepsis
- ClinicalTrials.gov ID
- NCT07131969
- Acronym / sponsor ID
- MAP-ALF / A097365
- Conditions
- Acute Liver Failure, Sepsis
- Keywords
- acute liver failure, sepsis, transcriptional analysis, predictors, paracetamol overdose, acetaminophen overdose
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- 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.
Context Acute liver failure (ALF) is a life-threatening condition that occurs on the background of a healthy liver. The most common cause of acute liver failure in the UK is paracetamol overdose. Acute liver failure results from liver damage and activation of the body's inflammatory defences with subsequent damage to other organs including kidneys, lungs and heart. This often requires life support in an intensive care unit before liver transplantation (LT), the only currently available and effective rescue treatment for acute liver failure.
Challenge Patient factors and organ availability limit who can benefit from liver transplant. At present there are no effective alternative therapies for patients who do not get a liver transplant, and survival rates in these situations are poor. The underlying mechanisms of inflammation are poorly understood, thus therapies are limited.
Aim The investigators research aims to understand the mechanisms that underpin the inflammation seen in acute liver failure by studying the inflammatory cells in the blood and examining their cellular programmes. This will allow the investigators to identify pathways that are activated and understand how the liver and blood interact to spread inflammation around the body. The investigators aim to identify targets for disease-modifying therapies to avert the need for liver transplant.
Importance Understanding how the body responds to acute liver failure, and whether there are different patterns of inflammatory response, will enable trials of immune-modulating drugs to prevent the need for liver transplantation or prolong the time a patient can wait for an organ. This has the potential to help improve organ availability for other patients and save lives in acute liver failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute liver failure or sepsis | – | Other: blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute liver failure due to acetaminophen overdose OR sepsis who are admitted to ICU
Key inclusion criteria (2 listed)
- acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU
- all cause sepsis admitted to ICU
Key exclusion criteria (1 listed)
- age <16y
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 |
|---|---|---|
| blood drawVenous blood sampling into Tempus tube for RNA-sequencing | Other | Patients with acute liver failure or sepsis |
Primary outcome
Mortality
Time frame: From enrolment until at least 1-year
3 secondary outcomes
Transplant free survival
Time frame: From enrolment to at least one year
Length of stay - ICU and hospital
Time frame: From enrolment
Transplant free mortality
Time frame: From enrolment until death (at least until 1year)
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 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure and Sepsis, run by University of Cambridge at 7 sites in United Kingdom.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mortality (time frame: From enrolment until at least 1-year). 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 26 Aug 2025.