Caraceni P, et al. - An investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial was performed to determine the effectiveness of long-term human albumin (HA) administration in patients with decompensated cirrhosis. Results of this study suggested that in patients with decompensated cirrhosis, long-term HA administration prolongs overall survival and could act as a disease modifying treatment.

Methods

• This trial was conducted in 33 academic and non-academic Italian hospitals.
• For this investigation, patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months were randomly assigned.
• Eighteen month mortality was the primary endpoint, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations.

Results

• Four hundred forty patients were randomly assigned and 431 were involved in the modified intention-to-treat analysis from April 2, 2011, to May 27, 2015.
• It was observed in the findings that 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group.
• Findings revealed that 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]).
• The results of this study showed that 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events.