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
  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:


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 April 22, 2014