Sodium Restriction in the Management of Cirrhotic Ascites

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ascites

Intervention / Treatment
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* Other: Sodium restriction
* Other: Sodium restriction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 gram sodium diet | Other: Sodium restriction<br>* 4 gram sodium diet<br>* Other names: No added salt diet;|
| Active Comparator: 2<br>2 gram sodium diet | Other: Sodium restriction<br>* 2 gram sodium diet<br>* Other names: Low sodium diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of ascites |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance and compliance |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, portal hypertension, ascites, sodium restriction