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

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ClinicalTrials.gov Identifier: NCT00428506
Recruitment Status : Unknown
Verified April 2008 by University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : January 30, 2007
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
University of Turin, Italy

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


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

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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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