Sodium Restriction in the Management of Cirrhotic Ascites

Phase 4TerminatedNCT00548366

University of Texas Southwestern Medical Center68 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ascites

Interventions

Sodium restrictionOTHER

4 gram sodium diet

Sodium restrictionOTHER

2 gram sodium diet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Parkland Memorial Hospital

Dallas, Texas, United States

Outcomes

Primary Outcomes

Control of ascites

Time frame: 3 months

Secondary Outcomes

Patient acceptance and compliance

Time frame: 3 months

Data from ClinicalTrials.gov

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