Sodium Restriction in the Management of Cirrhotic Ascites

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548366

Enrollment

Registered

2007-10-23

Start date

2007-10-31

Completion date

2010-09-30

Last updated

2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites

Keywords

cirrhosis, portal hypertension, ascites, sodium restriction

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

Interventions

OTHERSodium restriction

4 gram sodium diet

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Control of ascites	3 months

Secondary

Measure	Time frame
Patient acceptance and compliance	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026