Sodium Restriction in the Management of Cirrhotic Ascites
NCT ID: NCT00548366
Last Updated: 2010-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
68 participants
INTERVENTIONAL
2007-10-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
4 gram sodium diet
Sodium restriction
4 gram sodium diet
2
2 gram sodium diet
Sodium restriction
2 gram sodium diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium restriction
4 gram sodium diet
Sodium restriction
2 gram sodium diet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
UT Southwestern Medical Center at Dallas
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer A Cuthbert, M.D.
Role: STUDY_DIRECTOR
UT Southwestern Medical Center at Dallas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parkland Memorial Hospital
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UTSouthwestern 062007-066
Identifier Type: -
Identifier Source: org_study_id