Objectives: To compare the hospital costs associated with two fluid resuscitation strategies for cirrhotic ascites: one with human albumin 20% (Vialebex 20%) and one with polygeline.
Methods: Multicenter prospective randomized double-blinded comparative trial (that also compared efficacy and tolerance). The economic evaluation was based on direct medical costs throughout the follow-up period: days of hospitalization, hospital consultations, medical procedures, and fluid resuscitation products. This cost-minimization study had a 6-month follow-up period. Daily costs in euros were adjusted over a 30-day period. The study was interrupted prematurely because of an alert due to the bovine origin of the polygeline, and the inclusion objectives could therefore not be met.
Results: The economic analysis included all patients in the efficacy population (group receiving human albumin 20%: n=30, polygeline group: n=38). It found a standardized cost per patient for 30 days of treatment that was significantly lower (p=0.004) for human albumin 20% (median: 1915 euro; range: 1330-4105) than for polygeline (median: 4612 euro; range: 2138-12234). This difference is related mainly to a reduction in the frequency and duration of hospitalization in specialized units, but also to other aspects of management: hospitalization in other departments, specific solutions for the study products, and hospital procedures.
Conclusion: The economic results of this trial favor a fluid resuscitation strategy that uses human albumin 20% for cirrhotic patients. They are consistent with the clinical results and help assess the cost-benefit ratio of human albumin 20% for this indication.