Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood draw.
- Who it may be relevant to
- Registry conditions: Acute Liver Failure, Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcriptional Analysis of Mechanisms and Predictors in Acute Liver Failure and Sepsis
Overview
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.
Interventions
- Other blood draw
Venous blood sampling into Tempus tube for RNA-sequencing
Primary outcome measures
- Mortality [Time frame: From enrolment until at least 1-year]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
Inclusion criteria
- acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU
- all cause sepsis admitted to ICU
Exclusion criteria
- age <16y
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 7 centers
- University Hospitals Birmingham — Birmingham
- Addenbrooke's Hospital — Cambridge
- Royal Infirmary of Edinburgh — Edinburgh
- Leeds General Infirmary — Leeds
- Kings College Hospital — London
- Royal Free Hospital — London
- Freeman Hospital — Newcastle
Identifiers
NCT: NCT07131969 · A097365