Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cambridge

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU

all cause sepsis admitted to ICU

Disqualifiers

age <16y

Trial population

Patients with acute liver failure due to acetaminophen overdose OR sepsis who are admitted to ICU

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood draw

    Other intervention

    Venous blood sampling into Tempus tube for RNA-sequencing

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with acute liver failure or sepsis1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Time frame
From enrolment until at least 1-year

Secondary outcomes

1

Transplant free survival

30-day and 1-year survival without transplant

Time frame
From enrolment to at least one year
2

Length of stay - ICU and hospital

Number of days stayed in ICU and in-hospital

Time frame
From enrolment
3

Transplant free mortality

Death without transplant

Time frame
From enrolment until death (at least until 1year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cambridge

Lead sponsor

European Society of Intensive Care Medicine

Collaborator

This trial is not recruiting at the moment. You can still explore other options: