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

NCT ID: NCT00428506

Last Updated: 2008-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-12-31

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.

Conditions

Tense Ascites in Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

albumin 4 gr/L ascites removed

albumin 4 gr/L ascites removed

Intervention Type: DRUG

albumin 8 gr/L ascites removed

albumin 8 gr/L ascites removed

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Mario Rizzetto

Principal Investigators

Mario Rizzetto, MD

Role: STUDY_DIRECTOR

Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy

Locations

San Giovanni Battista Hospital

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Alessandria, MD

Role: CONTACT

carloalessandria@libero.it

+390116335561

Facility Contacts

Carlo Alessandria, MD

Role: primary

carloalessandria@libero.it

+3901163335561

References

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.

Reference Type: BACKGROUND

PMID: 12717396 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8831595 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21741331 (View on PubMed)

Other Identifiers

ALB-PPCD

Identifier Type: -

Identifier Source: org_study_id