Real-life experience of long-term albumin treatment for the management of ascites in patients with decompensated cirrhosis accross Italy

Background and Aims Long-term albumin (LTA) has become standard of care for patients with decompensated cirrhosis in many Italian hepatological centres. This study aimed to address several issues related to patients and treatment still undefined in real-life practice. Methods This multicenter retrospective observational study included patients with cirrhosis and ascites receiving LTA (at least one month) between 01/2016 and 02/2022. Data on patient characteristics, albumin treatment, clinical courses and outcomes were collected. Results 312 patients, the majority with alcoholic cirrhosis, were included in 5 Italian centers. At baseline, median Child-Pugh was 8, MELD 15 and MELD-Na 18. In 55% of patients, ascites was grade 2, in 36% grade 3 and in 28% refractory, while 47% had paracentesis in the previous 6 months. Median LTA was about 10 months with a median dose of 40 g/week. Albumin was infused in territorial services in 44% of cases and only 1% discontinued due to logistic reasons. Ascites resolved to grade 0-1 in 34% of patients within the first 3 months and 61% at the end of treatment. Among patients receiving paracenteses prior LTA, about 40% had no paracentesis at 6 months. Factors independently associated with ascites resolution were grade 2 ascites and INR at baseline, albumin dose, serum albumin of 38 g/l at 1 month and no paracentesis in the previous 6 months. Interestingly, 75 patients, including some with refractory ascites, discontinued LTA due to clinical improvement. No adverse events were reported. Conclusions LTA is feasible, safe and very effective in treating ascites, with almost 25% of patients being able to stop treatment for ascites resolution. Patients with uncomplicated ascites appear the best candidates to LTA, although those with refractory ascites may also benefit of treatment. Confirming previous data, on-treatment serum albumin concentration close to 40 g/l predicts a better response.