Status:
UNKNOWN
Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction
Lead Sponsor:
University of Turin, Italy
Conditions:
Tense Ascites in Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the preventi...
Detailed Description
Large-volume paracentesis associated with plasma volume expansion is the first-line treatment of tense ascites in cirrhotic patients. When paracentesis is performed without volume expansion, an high p...
Eligibility Criteria
Inclusion
- Cirrhosis and ascites submitted to paracentesis \> 5 liters
- Age: 18-75 years
- Informed written consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00428506
Start Date
February 1 2007
End Date
December 1 2008
Last Update
April 11 2008
Active Locations (1)
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1
San Giovanni Battista Hospital
Turin, Italy, 10126