Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Ascites is the most frequent complication of liver cirrhosis and carries a significant
worsening of the prognosis. Approximately 10% of patients per year develop refractory ascites
because of either the lack of response to medical treatment or the onset of diuretic-induced
complications that preclude the use of an effective dosage. Refractory ascites is associated
with an increased incidence of severe complications of cirrhosis. Thus, the overall
probability of survival of patients with refractory ascites is very poor, being approximately
30% at 2 years. Repeated large-volume paracentesis, transjugular intrahepatic portosystemic
shunt (TIPS), and liver transplantation represent the therapeutic alternatives for refractory
ascites. As renal sodium retention and ascites formation are the consequence of portal
hypertension and effective hypovolemia, the preservation of the central blood volume
represents a major purpose in the management of patients with advanced cirrhosis. Although
albumin is responsible for about 70% of the plasma oncotic pressure, the absence of large
multicenter randomized studies together with its high cost explains why albumin infusion is
not usually included among the therapeutic options for difficult-to-treat ascites.
The objective of the present study is to define the effectiveness of the prolonged
administration of human albumin in the treatment of liver cirrhosis with ascitic
decompensation. This goal will be reached by performing a multicenter, prospective,
randomized clinical trial comparing the efficacy of chronic albumin administration on top of
standard medical treatment versus standard medical treatment alone in patients with cirrhosis
and ascites.
The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or
out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized
with a ratio of 1:1. The duration of the study for each patient is 18 months from
randomization. The enrolment of patients will last 18 months and will be competitive between
centers. Treatment will be interrupted if one of the following condition occur: orthotopic
liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient
refusal to continue, and medical judgement.
An ancillary optional study will be performed in a subset of patients to analyze the
non-oncotic properties of albumin.