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Sodium Restriction in the Management of Cirrhotic Ascites

This study has been terminated.
(Failure to recruit.)
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00548366
First received: October 22, 2007
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Ascites
 Other: Sodium restriction
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Control of ascites [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient acceptance and compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4 gram sodium diet
 Other: Sodium restriction
4 gram sodium diet
Other Name: No added salt diet
Active Comparator: 2
2 gram sodium diet
 Other: Sodium restriction
2 gram sodium diet
Other Name: Low sodium diet

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548366

Locations
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Director: Jennifer A Cuthbert, M.D. UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: Jennifer Cuthbert, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00548366     History of Changes
Other Study ID Numbers: UTSouthwestern 062007-066
Study First Received: October 22, 2007
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
cirrhosis
portal hypertension
ascites
sodium restriction

Additional relevant MeSH terms:
Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013