Sodium Restriction in the Management of Cirrhotic Ascites

September 10, 2010 updated by: University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
4 gram sodium diet
Other: Sodium restriction
4 gram sodium diet
Other Names:
  • No added salt diet
Other: Sodium restriction
2 gram sodium diet
Other Names:
  • Low sodium diet
Active Comparator: 2
2 gram sodium diet
Other: Sodium restriction
4 gram sodium diet
Other Names:
  • No added salt diet
Other: Sodium restriction
2 gram sodium diet
Other Names:
  • Low sodium diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Control of ascites
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient acceptance and compliance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Study Director: Jennifer A Cuthbert, M.D., UT Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTSouthwestern 062007-066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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