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

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

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

Study Overview

• Status: Unknown
• Conditions: Tense Ascites in Cirrhosis
• Intervention / Treatment: Drug: albumin 4 gr/L ascites removed; Drug: albumin 8 gr/L ascites removed

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • San Giovanni Battista Hospital
    • Contact: Carlo Alessandria, MD; Phone Number: +3901163335561; Email: carloalessandria@libero.it
    • Sub-Investigator: Alfredo Marzano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
renin-angiotensin-aldosterone activation	4-6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
renal function	4-6 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Study Director: Mario Rizzetto, MD, Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy

Publications and helpful links

General Publications

• Sola-Vera J, Minana J, Ricart E, Planella M, Gonzalez B, Torras X, Rodriguez J, Such J, Pascual S, Soriano G, Perez-Mateo M, Guarner C. Randomized trial comparing albumin and saline in the prevention of paracentesis-induced circulatory dysfunction in cirrhotic patients with ascites. Hepatology. 2003 May;37(5):1147-53. doi: 10.1053/jhep.2003.50169.
• Gines A, Fernandez-Esparrach G, Monescillo A, Vila C, Domenech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Sola R, Gines P, Terg R, Inglada L, Vaque P, Salerno F, Vargas V, Clemente G, Quer JC, Jimenez W, Arroyo V, Rodes J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10. doi: 10.1016/s0016-5085(96)70068-9.
• Alessandria C, Elia C, Mezzabotta L, Risso A, Andrealli A, Spandre M, Morgando A, Marzano A, Rizzetto M. Prevention of paracentesis-induced circulatory dysfunction in cirrhosis: standard vs half albumin doses. A prospective, randomized, unblinded pilot study. Dig Liver Dis. 2011 Nov;43(11):881-6. doi: 10.1016/j.dld.2011.06.001. Epub 2011 Jul 8.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: January 26, 2007
• First Submitted That Met QC Criteria: January 29, 2007
• First Posted (Estimate): January 30, 2007

Study Record Updates

• Last Update Posted (Estimate): April 11, 2008
• Last Update Submitted That Met QC Criteria: April 9, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: albumin; cirrhosis; ascites; post-paracentesis circulatory dysfunction; portal-hypertension
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Ascites
• Other Study ID Numbers: ALB-PPCD