Sodium Restriction in the Management of Cirrhotic Ascites - Full Text View

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00548366

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 IV

MedlinePlus related topics: Dietary Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites

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

Primary Outcome Measures:

Control of ascites [ Time Frame: 3 months ]

Secondary Outcome Measures:

Patient acceptance and compliance [ Time Frame: 3 months ]

Estimated Enrollment:	68
Study Start Date:	October 2007

Arms	Assigned Interventions
1: Experimental 4 gram sodium diet	Other: Sodium restriction 4 gram sodium diet
2: Active Comparator 2 gram sodium diet	Other: Sodium restriction 2 gram sodium diet

Detailed Description:

Secondary objectives:

Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
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

Contacts

Contact: Vincent Chan, M.D.	214-648-2706	VCHAN@parknet.pmh.org
Contact: Jennifer Cuthbert, M.D.	214-648-2706	jennifer.cuthbert@utsouthwestern.edu

Locations

United States, Texas
Parkland Memorial Hospital	Recruiting
Dallas, Texas, United States, 75235
Contact: Vincent Chan, M.D. 214-648-2706 VCHAN@parknet.pmh.org
Principal Investigator: Vincent Chan, M.D.

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

Study ID Numbers:	UTSouthwestern 062007-066
Study First Received:	October 22, 2007
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00548366
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

cirrhosis
portal hypertension
ascites
sodium restriction

Study placed in the following topic categories:

Ascites
Hypertension, Portal
Liver Cirrhosis
Portal hypertension
Hypertension

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009