Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Use of Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis: a Multicenter, Open-label Randomized Clinical Trial
Brief 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.


Options:
A: Arm Label: HES 130/0.4; Type: EXPERIMENTAL; Interventions: Drug: 6% Hydroxyethyl starch 130/0.4 | Arm Label: Ringer acetate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ringers acetate | Intervention Type: DRUG; Name: 6% Hydroxyethyl starch 130/0.4; Assigned to Arm(s): HES 130/0.4 | Intervention Type: DRUG; Name: Ringers acetate; Assigned to Arm(s): Ringer acetate
B: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Human Albumin | Intervention Type: DRUG; Name: Human Albumin; Assigned to Arm(s): 2
C: Arm Label: Standard medical treatment plus albumin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Diuretics plus human albumin | Arm Label: Standard medical treatment; Type: OTHER; Interventions: Drug: Diuretics (standard medical treatment) | Intervention Type: DRUG; Name: Diuretics plus human albumin; Assigned to Arm(s): Standard medical treatment plus albumin | Intervention Type: DRUG; Name: Diuretics (standard medical treatment); Assigned to Arm(s): Standard medical treatment
D: Arm Label: Albumin plus midodrine; Type: ACTIVE_COMPARATOR; Interventions: Drug: albumin, Drug: Midodrine | Arm Label: salin solution plus pills; Type: PLACEBO_COMPARATOR; Interventions: Drug: albumin, Drug: Placebo | Intervention Type: DRUG; Name: albumin; Assigned to Arm(s): Albumin plus midodrine, salin solution plus pills | Intervention Type: DRUG; Name: Midodrine; Assigned to Arm(s): Albumin plus midodrine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): salin solution plus pills

Answer: C