Clinical Trial: Sodium Restriction in the Management of Cirrhotic Ascites
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites
Brief 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.
Detailed Summary:
Secondary objectives:
- Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
- Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
- 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
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Control of ascites [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient acceptance and compliance [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: October 22, 2007
Date Started: October 2007
Date Completion:
Last Updated: September 10, 2010
Last Verified: September 2010
