| Albumin To prevenT Infection in chronic liveR failurE (ATTIRE) |
Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)
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| Specialty |
| Hepatology |
| Portfolio Eligibility |
| Automatically eligible |
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| ISRCTN | 14174793 |
| EudraCT | 2014-002300-24 |
| MREC N° | 15/LO/0104 |
| UKCRN ID | 18450 |
| WHO ID | |
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| 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. |
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| Study Type | Interventional |
| Design Type | Prevention, Treatment |
| Disease(s) | All Hepatology |
| Phase | II/III |
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| Current Status | Open |
| Closure Date | 11/21/2017 |
| Global Sample Size | 946 |
| Global Recruitment to Date |
 2% |
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| Geographical Scope | UK Multi-Centre |
| Lead Country | England (also active in Wales) |
| Open to new sites | No |
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| Main Inclusion Criteria |
| • All patients admitted to hospital with acute onset or worsening of complications of cirrhosis e.g. alcoholic hepatitis, hepatic encephalopathy, ascites, hepatic hydrothorax, hyperbilirubinaemia, oesophageal variceal bleed, any infection precipitating acute decompensation or any other presentation of acute decompensation / acute onset chronic liver failure • Over 18 years of age • Predicted hospital admission > 5 days at trial enrolment, which must be within 72 hours of admission • Serum albumin <30g/l at screening • Documented informed consent to participate (or consent given by a legal representative) |
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| Main Exclusion Criteria |
| • Advanced hepatocellular carcinoma with life expectancy of less than 8 weeks • Patients who will receive palliative treatment only during their hospital admission • Patients who are pregnant • Severe cardiac dysfunction • Any clinical condition which the investigator considers would make the patient unsuitable for the trial • The patient has been involved in a clinical trial of Investigational Medicinal Products (IMPs) within the previous 30 days (including re-randomisation into the RCT) • Trial investigators unable to identify the patient (by NHS number) |
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| Chief Investigator(s) |
| Dr Alastair O'Brien |
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| Further details, please contact |
Miss Zainib Shabir
University College London
Gower Street
London
WC1E 6BT
UNITED KINGDOM
z.shabir@ucl.ac.uk |
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| Funder(s) | Department of Health
The Wellcome Trust |
| Sponsor(s) | University College London |
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