ascites in patients with hepatic cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10003445 Term: Ascites
Conditions
Interventions
Trade Name: ALBUM.U.KED.*IV FL 50ML20%+SET
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Albumin
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic and ultrasonographic features) and uncomplictaed ascites according to the criteria of the International Ascites Club (1). - Diuretic treatment, stable for at least 7 days prior the enrollemnt, with an antimineralocorticoid drug at a dose ≥ 200mg/day and furosemide ≥ 25mg/day. With this limitation, we aim to identify a fairly homogeneous population with a relatively advanced stage of the disease that will likely have more benefit from albumin administration, as also suggested by Gentilini at al. (17). - EGDS performed in the last 12 months, abdominal ultrasonography performed in the last 30 days, and laboratory tests required by the protocol in the last 7 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age lower than 18 years - No written informed consent - Inability to follow written consent - Ongoing alcohol abuse (patients should be abstinent for at least three monts) - Established diagnosis of refractory ascites, as defined by the IAC (1) - Need of 3 or more paracentesis during the last two months - Serum creatinine > 1.6 mg/dl - Patients with TIPS or other surgical porto-caval shunts - Budd-Chiari Syndrome - Previous liver transplantation - Known hepatocellular carcinoma or other malignancies - Current / recent gastrointestinal bleeding, bacterial infection or type 1 hepatorenal syndrome - Renal failure due to intrinsic nephropathy - Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) - Known or suspected hypersensitivity to albumin - Pregnancy and breast-feeding - Use of experimental drugs for the last 2 months prior the inclusion in the present study - Females of child-bearing potential are excluded unless they meet one of the following criteria: o Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test o Surgical sterilisation for more than one month duration and a negative pregnancy test o Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives are: - increase in survival - improvement in the response to standard medical treatment and avoid/delay the occurrence of refractory ascites in patients with cirrhosis and uncomplicated ascites.;Secondary Objective: Secondary objectives are: - to avoid/delay the need of transjugular intrahepatic porto-systemic shunt in patients with refractory ascites - reduction in the incidence of disease- and/or diuretic-related complications - improvement in the quality of life - reduction of the costs of patient management.;Primary end point(s): Primary outcomes. 1) reduction in the 24 month mortality; 2) reduction in the 24 month incidence of refractory ascites | — |
Countries
Italy
Outcome results
None listed