The INFECIR-2 Albumin Prevention Study
Research type
Research Study
Full title
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.
IRAS ID
151828
Contact name
Rajiv Jalan
Contact email
Sponsor organisation
Fundacio Clinic per a la recerca biomedica
Eudract number
2013-002416-27
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients with liver cirrhosis are at increased risk of developing infections such as spontaneous bacterial peritonitis (which is an infection of the abdominal cavity), urinary, skin or respiratory (breathing related) infections. The inflammation that is caused by the infection can lead to the development of complications, such as kidney failure, liver failure or brain failure. Patients that already have poor liver or kidney function when they develop an infection are at increased risk of further problems that often result in a poor outcome.
Several research studies have shown that the administration of a serum called albumin (serum is the term for the part of blood that is like water) is effective (meaning that it works well) in decreasing the occurrence of kidney failure and liver failure with in patients with spontaneous bacterial peritonitis.
The purpose of this study is to help us understand if albumin is also effective in patients who have advanced liver disease that have infections other than spontaneous bacterial peritonitis.
The study will enroll 512 adult patients from 28 hospital sites around Europe.Potential patients will be informed about the study and asked if they would like to participate. Following written informed consent, patients will be screened to ensure they meet all eligibility criteria and then will be randomised into one of two groups: Standard medical therapy (antibiotics) or Standard medical therapy plus albumin infusion.
Patients will be treated as per normal clinical management of their disease. Blood samples collected additionally to normal clinical management are blood samples collected at Day 1, 3 and at resolution of infection (or Day 7) to evaluate hormonal and inflammatory markers. These will be shipped to a central lab for analysis. If patients agree they may also participate in additional blood draws for analysis of potential molecular/genetic factors that may cause liver disease.REC name
London - Central Research Ethics Committee
REC reference
15/LO/0285
Date of REC Opinion
26 Jun 2015
REC opinion
Further Information Favourable Opinion