Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis

Официальное название

Transcriptional Analysis of Mechanisms and Predictors in Acute Liver Failure and Sepsis

Обзор

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.

Вмешательства

• Другое blood draw
  Venous blood sampling into Tempus tube for RNA-sequencing

Первичные конечные точки

• Mortality [Срок оценки: From enrolment until at least 1-year]

Вторичные конечные точки (3)

• Transplant free survival [Срок оценки: From enrolment to at least one year]
• Length of stay - ICU and hospital [Срок оценки: From enrolment]
• Transplant free mortality [Срок оценки: From enrolment until death (at least until 1year)]

Критерии участия

Критерии включения

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

Критерии исключения

• age <16y

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 7 центров

• 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

Идентификаторы

NCT: NCT07131969 · A097365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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