Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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:

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:
    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
Ages Eligible for Study:   18 Years to 75 Years
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:

Additional 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
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

ClinicalTrials.gov processed this record on March 03, 2015