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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by University of Turin, Italy.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428506
First Posted: January 30, 2007
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Turin, Italy
  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
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

Resource links provided by NLM:

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 ]

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

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
  Contacts and Locations
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
  More Information

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 Submitted: January 26, 2007
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