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

Primary Purpose

Tense Ascites in Cirrhosis

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
albumin 4 gr/L ascites removed
albumin 8 gr/L ascites removed
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tense Ascites in Cirrhosis focused on measuring ascites, cirrhosis, post-paracentesis circulatory dysfunction, albumin, portal-hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Giovanni Battista HospitalRecruiting

Outcomes

Primary Outcome Measures

renin-angiotensin-aldosterone activation

Secondary Outcome Measures

renal function

Full Information

First Posted
January 26, 2007
Last Updated
April 9, 2008
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00428506
Brief Title
Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction
Official Title
Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tense Ascites in Cirrhosis
Keywords
ascites, cirrhosis, post-paracentesis circulatory dysfunction, albumin, portal-hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
albumin 4 gr/L ascites removed
Intervention Description
albumin 4 gr/L ascites removed
Intervention Type
Drug
Intervention Name(s)
albumin 8 gr/L ascites removed
Intervention Description
albumin 8 gr/L ascites removed
Primary Outcome Measure Information:
Title
renin-angiotensin-aldosterone activation
Time Frame
4-6 days
Secondary Outcome Measure Information:
Title
renal function
Time Frame
4-6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Alessandria, MD
Phone
+390116335561
Email
carloalessandria@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Rizzetto, MD
Organizational Affiliation
Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy
Official's Role
Study Director
Facility Information:
Facility Name
San Giovanni Battista Hospital
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Alessandria, MD
Phone
+3901163335561
Email
carloalessandria@libero.it
First Name & Middle Initial & Last Name & Degree
Alfredo Marzano, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12717396
Citation
Sola-Vera J, Minana J, Ricart E, Planella M, Gonzalez B, Torras X, Rodriguez J, Such J, Pascual S, Soriano G, Perez-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. doi: 10.1053/jhep.2003.50169.
Results Reference
background
PubMed Identifier
8831595
Citation
Gines A, Fernandez-Esparrach G, Monescillo A, Vila C, Domenech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Sola R, Gines P, Terg R, Inglada L, Vaque P, Salerno F, Vargas V, Clemente G, Quer JC, Jimenez W, Arroyo V, Rodes J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10. doi: 10.1016/s0016-5085(96)70068-9.
Results Reference
background
PubMed Identifier
21741331
Citation
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.
Results Reference
derived

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

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