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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Drug: albumin 4 gr/L ascites removed
- renin-angiotensin-aldosterone activation [ Time Frame: 4-6 days ]
- renal function [ Time Frame: 4-6 days ]
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, MDfirstname.lastname@example.org|
|San Giovanni Battista Hospital||Recruiting|
|Turin, Italy, 10126|
|Contact: Carlo Alessandria, MD +3901163335561 email@example.com|
|Sub-Investigator: Alfredo Marzano, MD|
|Study Director:||Mario Rizzetto, MD||Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy|