Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis (ANSWER)
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|ClinicalTrials.gov Identifier: NCT01288794|
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : January 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Ascites||Drug: Diuretics plus human albumin Drug: Diuretics (standard medical treatment)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||431 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis: a Multicenter, Open-label Randomized Clinical Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||May 2016|
Active Comparator: Standard medical treatment plus albumin
The patients will receive standard medical treatment (diuretics) plus weekly albumin infusion
Drug: Diuretics plus human albumin
The patients will receive standard medical treatment plus albumin infusion at the dose of 40 g twice weekly for 2 weeks, and then 40 g weekly for the rest of the study (up to 24 months).
Standard medical treatment
The patients will receive the standard medical treatment (diuretics), but non albumin for the therapy of ascites
Drug: Diuretics (standard medical treatment)
The patients will receive standard medical treatment (diuretics)
Other Name: Furosemide and antialdosteronic drugs
- Mortality [ Time Frame: 18 months ]
- Incidence of cirrhosis-related clinical complications [ Time Frame: 18 months ]
- Number of total paracentesis [ Time Frame: 18 months ]
- Number of patients potentially needing TIPS (3 paracentesis/month) [ Time Frame: 18 months ]
- Quality of life [ Time Frame: 18 months ]QoL will be assessed by the SF-36 and EQ-5D questionnaires
- Analysis of the cost/effectiveness ratio [ Time Frame: 18 months ]
- Incidence of refractory ascites according to the IAC criteria [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288794
|Principal Investigator:||Mauro Bernardi, MD||University of Bologna|
|Study Director:||Paolo Caraceni, MD||University of Bologna|