Sodium Restriction in the Management of Cirrhotic Ascites

Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00548366
• Other study ID #: UTSouthwestern 062007-066
• Status: Terminated
• Phase: Phase 4
• First received: October 22, 2007
• Last updated: September 10, 2010
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites

Intervention

Other:
• Sodium restriction
4 gram sodium diet
• Sodium restriction
2 gram sodium diet

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of ascites		3 months	No
Secondary	Patient acceptance and compliance		3 months	No