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

Tense Ascites in Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00428506
• Other study ID #: ALB-PPCD
• Status: Recruiting
• Phase: Phase 2
• First received: January 26, 2007
• Last updated: April 9, 2008
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: University of Turin, Italy
• Contact: Carlo Alessandria, MD
• Phone: +390116335561
• Email: carloalessandria[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ascites
• Tense Ascites in Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Italy	San Giovanni Battista Hospital	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renin-angiotensin-aldosterone activation		4-6 days	Yes
Secondary	renal function		4-6 days	Yes