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Study type

Phase IV, open-label, multicenter European RCT involving liver units with expertise in management of patients with decompensated liver cirrhosis. Patients with advanced cirrhosis (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l and/or serum bilirubin ≥4 mg/dl), signs of systemic inflammation and urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be included. Patients will be randomized into two groups at the time of the diagnosis of infection:

Standard medical therapy (antibiotics)
Standard medical therapy plus IV albumin (albumin group)

Aim of the Study

The aim of this study is to evaluate if IV albumin administration improves short-term survival in patients with advanced cirrhosis (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l and/or serum bilirubin ≥4 mg/dl), signs of systemic inflammation and bacterial infections other than spontaneous bacterial peritonitis (urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection).

Primary goals

Effect of albumin administration on hospital and 28-day survival.

Secondary goals

Effect of albumin administration on 90-day survival.
Effect of albumin administration on the incidence of renal dysfunction, type-1 and 2 HRS during hospitalization.
Etc.