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Sponsored by: |
University of Turin, Italy |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00428506 |
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 II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites |
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) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Mario Rizzetto ( University of Turin ) |
Study ID Numbers: | ALB-PPCD |
Study First Received: | January 26, 2007 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00428506 |
Health Authority: | Italy: Ministry of Health |
ascites cirrhosis post-paracentesis circulatory dysfunction albumin portal-hypertension |
Fibrosis Ascites Hypertension, Portal |
Liver Cirrhosis Portal hypertension Hypertension |
Pathologic Processes |