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Sodium Restriction in the Management of Cirrhotic Ascites

Ascites Clinical Trial

Official title:
Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites

Clinical Trial Summary

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Clinical Trial Description

Secondary objectives:

1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet

2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet

3. Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00548366
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase Phase 4
Start date October 2007
Completion date September 2010
View Details
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