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
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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 |
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 |

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Drug: albumin 4 gr/L ascites removed
- renin-angiotensin-aldosterone activation [ Time Frame: 4-6 days ]
- renal function [ Time Frame: 4-6 days ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Carlo Alessandria, MD | +390116335561 | carloalessandria@libero.it |
Italy | |
San Giovanni Battista Hospital | Recruiting |
Turin, Italy, 10126 | |
Contact: Carlo Alessandria, MD +3901163335561 carloalessandria@libero.it | |
Sub-Investigator: Alfredo Marzano, MD |
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 |