Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)
Research type
Research Study
Full title
Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)
IRAS ID
158474
Contact name
Alastair O'Brien
Contact email
Eudract number
2014-002300-24
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Liver disease is the fifth most common cause of death in the UK and is caused largely by alcohol, viruses and fatty liver disease resulting in liver damage and loss of function. People can survive with large amounts of liver damage but often have severe health complications leading to frequent hospital admissions. In particular, patents have weak immune systems and are highly prone to bacterial infection with over a third developing an infection in hospital. Infection is the major cause of death in these patients and therefore represents a huge challenge to the NHS.
Currently infection in liver patients is treated with antibiotics, however the rates of death in these patients have shown little improvement over 20 years. Antibiotics may also cause harmful side-effects (e.g. diarrhoea) and overuse has led to antibiotic resistant bacteria which makes these drugs useless and will be one of medicines’ greatest challenges over the next decade.
Our study aims to see if giving liver patients Human Albumin Solution restores their immune response and helps both prevent and improve treatment of infections. Albumin is a protein found naturally in blood and is made in the liver. As liver function reduces so does albumin production and blood levels fall. Albumin is safe and currently used in patients with liver failure; however, prescription is varied and although considered beneficial the effects havent been tested in clinical trials
This study includes a feasibility study, to verify whether it is possible to restore albumin levels to near normal. This will be followed by a randomised control trial to confirm whether restoring albumin levels improves survival from infection compared to standard treatment.
The study will take place at up to 40 NHS sites in England, Wales and Scotland involving 946 patients and is supported by the Department of Health and the Wellcome Trust.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0104
Date of REC Opinion
20 Mar 2015
REC opinion
Further Information Favourable Opinion