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Multicenter, randomized, controlled, double-blind trial comparing albumin with polygeline for intravascular fluid loading in patients with cirrhosis and ascites



Multicenter, randomized, controlled, double-blind trial comparing albumin with polygeline for intravascular fluid loading in patients with cirrhosis and ascites



Hepatology 38(4 Suppl 1): 420A-421A, October



Patients with cirrhosis and tense ascites often require repeated intravascular fluid loading with colloid solutions. It has been suggested that repeated fluid loading with human albumin may result in better outcomes than fluid loading with a synthetic colloid. Thus, we compared the outcomes and cost in patients with cirrhosis and tense ascites who were treated with albumin with those in patients treated with polygeline (a synthetic colloid). We conducted a six-month, multicenter, randomized, controlled, double-blind trial in patients with tense ascites who were assigned to receive either 20% human albumin or polygeline, not only after therapeutic paracentesis but also for complications that require fluid loading with a colloid. The trial was stopped early because French authorities were concerned about the possible transmission of nonconventional infectious agents through the administration of bovine-derived products such as polygeline. The prespecified end point was the number of liver-related events (i.e., a composite of death, episodes of recurrent tense ascites, renal impairment, hyponatremia, bacterial infection, encephalopathy, portal hypertensive bleeding, hepatocellular carcinoma, liver transplantation) during the in-trial period (i.e., the period when patients only received the assigned colloid). All events were adjudicated in a blind manner. Hospitalization-related costs, including those due to diagnostic and therapeutic procedures, were calculated. There were 30 patients assigned to albumin and 38 assigned to polygeline. At base line, all patients had therapeutic paracentesis and the treatment groups were well matched. The proportion of patients with a complete six-month follow-up was higher (40% vs. 16%) in the albumin group than in the polygeline group. The proportion of patients with early discontinuation of the assigned colloid due to trial interruption was similar in both treatment groups (33% vs. 29%). The proportion of patients who left the study because they died or returned to unblind colloid administration was lower in the albumin group than the polygeline group (3% vs. 8% and 24% vs. 47%, respectively). As a result, the in-trial period was longer in the albumin group than in the polygeline group (mean (+-SD), 122+-64 days vs. 78+-58 days; P=0.004). During this period, although compliance to protocol guidelines was good, as indicated by a similar number of units of colloid administered per session of fluid loading in the two treatment groups, the number of administered units of colloid per 100-patient days was lower in the albumin group (18.8+-24.4 vs. 35.3+-43.6, P=0.05). Consistent with this, the number of liver-related events (4.3+-5.0 vs. 9.6+-12.1, P=0.02) and the number of episodes of recurrent tense ascites (3.3+-4.1 vs. 7.0+-7.4, P=0.01), both calculated per 100-patient days, were lower in the albumin group than in the polygeline group. The hazard ratio for any liver-related first event in the albumin group as compared with the polygeline group was 0.64 (95% confidence interval, 0.45 to 1.36; P=0.38). The hazard ratio for first occurrence of renal impairment, or hyponatremia (a composite event) was 0.38 (95% confidence interval, 0.15 to 0.98; P=0.04). The cost per 30-patient days was lower in the albumin group than in the polygeline group (mean (95% confidence interval with logarithmic transformation), 3,114 (240-14,130) euros vs. 6,120 (540-31,560) euros; P=0.002). In conclusion, in patients with cirrhosis and tense ascites, a strategy using human albumin for repeated fluid loading leads to better outcomes than a strategy using polygeline. These beneficial effects of albumin may be associated with a significant decrease in hospitalization-related costs.

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Accession: 035349989

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