Patients with cirrhosis and tense ascites submitted to total paracentesis MedDRA version: 9.1 Level: LLT Classification code 10019845 Term: Hepatorenal failure
Conditions
Interventions
Trade Name: UMANALBUMIN FL 100ML 20%
Pharmaceutical Form: Solution for infusion
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0,2-
Sponsors
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cirrhosis and ascites submitted to paracentesis 5 liters Age 18-75 years Informed written consent 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: Multinodular HCC 3 nodules Portal vein thrombosis Ongoing bacterial infection Ongoing or recent less than one week bleeding Cardio-pulmonary failure Hepatorenal syndrome type 1 Severe coagulopathy platelets 30.000/mm3 and/or PT 30 Ongoing treatment with vasoactive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ;Secondary Objective: ;Primary end point(s): renin-angiotensin-aldosterone activation | — |
Countries
Italy
Outcome results
None listed