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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites

Conditions
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Tense Ascites in Cirrhosis

Intervention / Treatment
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* Drug: albumin 4 gr/L ascites removed
* Drug: albumin 8 gr/L ascites removed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renin-angiotensin-aldosterone activation |  | 4-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  | 4-6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascites, cirrhosis, post-paracentesis circulatory dysfunction, albumin, portal-hypertension