Sodium Restriction in the Management of Cirrhotic Ascites

Phase 4

Terminated

• Conditions: Ascites
• Interventions: Other: Sodium restriction

• Registration Number: NCT00548366
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2009-12
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sodium restriction	4 gram sodium diet
2	Sodium restriction	2 gram sodium diet

Primary Outcome Measures

Name	Time	Method
Control of ascites	3 months

Secondary Outcome Measures

Name	Time	Method
Patient acceptance and compliance	3 months

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States