Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis

NCT ID: NCT07131969

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Liver Failure Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute liver failure or sepsis

blood draw

Intervention Type OTHER

Venous blood sampling into Tempus tube for RNA-sequencing

Interventions

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blood draw

Venous blood sampling into Tempus tube for RNA-sequencing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU
* all cause sepsis admitted to ICU

Exclusion Criteria

* age \<16y
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Dhupal Patel

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals Birmingham

Birmingham, , United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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Andrew Conway-Morris

Role: primary

Andrew Ratcliffe

Role: primary

Mark McPhail

Role: primary

Amy Sangam

Role: primary

Iain McCullagh

Role: primary

Other Identifiers

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A097365

Identifier Type: -

Identifier Source: org_study_id

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