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TerminatedNCT00548366Updated Sep 14, 2010

Sodium Restriction in the Management of Cirrhotic Ascites

A Phase 4 interventional study of Sodium restriction and Sodium restriction in Ascites, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-14.

Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment

Why this study was terminated
Failure to recruit.
Phase
Phase 4
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Ascites

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Keywords

  • cirrhosis
  • portal hypertension
  • ascites
  • sodium restriction
03

In context

Ascites

252 studies on the registry are indexed under Ascites; 52 are open to participants now.

This study's planned enrollment of 68 is above the median of 55 across 177 interventional studies indexed under Ascites.

Browse Ascites studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 202 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 99 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    1

    4 gram sodium diet

    Other: Sodium restriction

  • Active comparator
    2

    2 gram sodium diet

    Other: Sodium restriction

Interventions

  • OtherSodium restriction

    4 gram sodium diet

    Also known as: No added salt diet

  • OtherSodium restriction

    2 gram sodium diet

    Also known as: Low sodium diet

06

What researchers measure

Primary outcomes

  1. Control of ascites

    Time frame: 3 months

Secondary outcomes

  1. Patient acceptance and compliance

    Time frame: 3 months

07

Study locations

1 site
  • Parkland Memorial Hospital
    Dallas, Texas 75235, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00548366
Lead sponsor
University of Texas Southwestern Medical Center
First posted
Oct 23, 2007
Start date
Oct 2007
Primary completion
Dec 2009
Completion
Sep 2010
Last update
Sep 14, 2010

Study contacts

Jennifer A Cuthbert, M.D.
study director · UT Southwestern Medical Center at Dallas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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