Expired Study
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Dallas, Texas 75235


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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.


NCT ID:

NCT00548366


Primary Contact:

Study Director
Jennifer A Cuthbert, M.D.
UT Southwestern Medical Center at Dallas


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75235
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 21, 2017

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