NCT00548366

Sodium Restriction in the Management of Cirrhotic Ascites

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Ascites

Interventions

Type	Name	Description
OTHER	Sodium restriction	4 gram sodium diet
OTHER	Sodium restriction	2 gram sodium diet

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-12-01
• Completion: 2010-09-01
• First posted: 2007-10-23
• Last updated: 2010-09-14

Locations

1 site across 1 country: United States