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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2008 by University of Turin, Italy.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT00428506

First received: January 26, 2007

Last updated: April 9, 2008

Last verified: April 2008

History of Changes

Purpose

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	Intervention	Phase
Tense Ascites in Cirrhosis	Drug: albumin 4 gr/L ascites removed Drug: albumin 8 gr/L ascites removed	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:

renin-angiotensin-aldosterone activation [ Time Frame: 4-6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

renal function [ Time Frame: 4-6 days ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	70
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

albumin 4 gr/L ascites removed

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428506

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

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
Study First Received:	January 26, 2007
Last Updated:	April 9, 2008
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Turin, Italy:


ascites cirrhosis post-paracentesis circulatory dysfunction albumin portal-hypertension

Additional relevant MeSH terms:


Fibrosis Ascites Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016

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