Sodium Restriction in the Management of Cirrhotic Ascites

Stopped early · Phase 4

Conditions studied: Ascites

In brief

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.

Key facts

Study ID

NCT00548366

Run by

University of Texas Southwestern Medical Center

People needed

68

Starts

2007-10-01

Expected to finish

2010-09-01

Last updated by the study team

2010-09-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
• Age 18-75
• Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
• Spanish-speaking subjects will be eligible for participation

You may not qualify if…

• Active drug or alcohol abuse,
• Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
• Hemorrhagic ascites, malignant ascites,
• Creatinine >2 mg/dL or CCl < 30 mL/min,
• K > 5.5 mmol/L,
• Diuretic refractory ascites
• Allergy to or intolerance of either spironolactone or furosemide
• Homelessness, incarceration, inability to follow up in clinic, or comply with diet.

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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