AscitesPhase 4NCT00548366
Sodium Restriction in the Management of Cirrhotic Ascites
A Phase 4 study testing Sodium restriction in people with Ascites, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ascites
- What is being tested?
- Sodium restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Ascites
- Being tested
- Sodium restriction
- Keywords
- cirrhosis, portal hypertension, ascites, sodium restriction
- Medical subject headings
- Ascites, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium restrictionOther
Also called No added salt diet
4 gram sodium diet
Sodium restrictionOther
Also called Low sodium diet
2 gram sodium diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4 gram sodium diet Receives: Other: Sodium restriction |
| 2 | Active comparator | 2 gram sodium diet Receives: Other: Sodium restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of ascites
Measured: 3 months
Secondary outcomes (1)
Patient acceptance and compliance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionSep 2010
Why it stopped: Failure to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jennifer A Cuthbert, M.D., Study director, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548366
- Sponsor's protocol ID
- UTSouthwestern 062007-066
- Status last verified
- Sep 2010
- First submitted
- 22 Oct 2007
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT00548366
- Acronym / sponsor ID
- UTSouthwestern 062007-066
- Conditions
- Ascites
- Keywords
- cirrhosis, portal hypertension, ascites, sodium restriction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit.
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Sodium restriction4 gram sodium diet |
| 2 | Active comparator | Other: Sodium restriction2 gram sodium diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium restrictionAlso: No added salt diet4 gram sodium diet | Other | 1 |
| Sodium restrictionAlso: Low sodium diet2 gram sodium diet | Other | 2 |
Primary outcome
Control of ascites
Time frame: 3 months
1 secondary outcome
Patient acceptance and compliance
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Failure to recruit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Cuthbert, M.D. study director
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium restriction in people with Ascites, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of ascites (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2010.