Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction

Phase 2

• Conditions: Tense Ascites in Cirrhosis

• Registration Number: NCT00428506
• Lead Sponsor: University of Turin, Italy

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 prevention of post-paracentesis circulatory dysfunction

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 proportion of patients develop a complication named post-paracentesis circulatory dysfunction, which is characterized by a marked activation of the renin-angiotensin-aldosterone system. PPCD has been associated with renal impairment, rapid recurrence of ascites and shorter survival. Infusion of albumin is very effective in the prevention of PPCD, but has sever inherent drawbacks: the theoretical possibility of transmission of infectious diseases and the high costs. Other synthetic plasma volume expanders have been proposed in the last decades, but they are less effective than albumin when large (\> 5 L) volume paracentesis are performed. Albumin is conventionally given in a dosage of 8 gr per liter of ascites removed; however no information has yet been reported on the use of lower dosages of albumin in this context. This would be interesting, because of the obvious advantages in terms of costs reduction.

The aim of the present study is to compare the efficacy of the infusion of albumin 4 gr vs 8 gr per liter of ascites removed in the prevention of PPCD.

Study Timeline

• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-29
• Study First Posted: 2007-01-30
• Study Start: 2007-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-09
• Last Update Posted: 2008-04-11
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Cirrhosis and ascites submitted to paracentesis > 5 liters
• Age: 18-75 years
• Informed written consent

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
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
renin-angiotensin-aldosterone activation	4-6 days

Secondary Outcome Measures

Name	Time	Method
renal function	4-6 days

Trial Locations

Locations (1)

San Giovanni Battista Hospital; 🇮🇹 Turin, Italy