Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites - ND
- Conditions
- Patients with cirrhosis and tense ascites submitted to total paracentesisMedDRA version: 9.1Level: LLTClassification code 10019845Term: Hepatorenal failure
- Registration Number
- EUCTR2007-001733-34-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s): renin-angiotensin-aldosterone activation
- Secondary Outcome Measures
Name Time Method