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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Tense Ascites in Cirrhosis	Drug: albumin 4 gr/L ascites removed; Drug: albumin 8 gr/L ascites removed	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
Study Start Date :	February 2007
Estimated Primary Completion Date :	December 2008
Estimated Study Completion Date :	December 2008

Arms and Interventions

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Intervention Details:

Drug: albumin 4 gr/L ascites removed
albumin 4 gr/L ascites removed
Drug: albumin 8 gr/L ascites removed
albumin 8 gr/L ascites removed

Outcome Measures

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Primary Outcome Measures :

1. renin-angiotensin-aldosterone activation [ Time Frame: 4-6 days ]

Secondary Outcome Measures :

1. renal function [ Time Frame: 4-6 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Carlo Alessandria, MD	+390116335561	carloalessandria@libero.it

Locations

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

Sponsors and Collaborators

University of Turin, Italy

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Sola-Vera J, Miñana J, Ricart E, Planella M, González B, Torras X, Rodríguez J, Such J, Pascual S, Soriano G, Pérez-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.

Ginès A, Fernández-Esparrach G, Monescillo A, Vila C, Domènech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Solà R, Ginès P, Terg R, Inglada L, Vaqué P, Salerno F, Vargas V, Clemente G, Quer JC, Jiménez W, Arroyo V, Rodés J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Turin, Mario Rizzetto
ClinicalTrials.gov Identifier:	NCT00428506 History of Changes
Other Study ID Numbers:	ALB-PPCD
First Posted:	January 30, 2007
Last Update Posted:	April 11, 2008
Last Verified:	April 2008

Keywords provided by University of Turin, Italy:

ascites; cirrhosis; post-paracentesis circulatory dysfunction; albumin; portal-hypertension

Additional relevant MeSH terms:

Fibrosis; Ascites; Pathologic Processes