Tense Ascites in Cirrhosis Clinical Trial
Official title:
Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction
Large-volume paracentesis associated with plasma volume expansion is the first-line
treatment of tense ascites in cirrhotic patients. When paracentesis is performed without
volume expansion, an high proportion of patients develop a complication named
post-paracentesis circulatory dysfunction, which is characterized by a marked activation of
the renin-angiotensin-aldosterone system. PPCD has been associated with renal impairment,
rapid recurrence of ascites and shorter survival. Infusion of albumin is very effective in
the prevention of PPCD, but has sever inherent drawbacks: the theoretical possibility of
transmission of infectious diseases and the high costs. Other synthetic plasma volume
expanders have been proposed in the last decades, but they are less effective than albumin
when large (> 5 L) volume paracentesis are performed. Albumin is conventionally given in a
dosage of 8 gr per liter of ascites removed; however no information has yet been reported on
the use of lower dosages of albumin in this context. This would be interesting, because of
the obvious advantages in terms of costs reduction.
The aim of the present study is to compare the efficacy of the infusion of albumin 4 gr vs 8
gr per liter of ascites removed in the prevention of PPCD.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention