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Sodium Restriction in the Management of Cirrhotic Ascites

Primary Purpose

Ascites

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sodium restriction

About this trial

This is an interventional treatment trial for Ascites focused on measuring cirrhosis, portal hypertension, ascites, sodium restriction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

4 gram sodium diet

2 gram sodium diet

Outcomes

Primary Outcome Measures

Control of ascites

Secondary Outcome Measures

Patient acceptance and compliance

Full Information

NCT ID

NCT00548366

First Posted

October 22, 2007

Last Updated

September 10, 2010

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00548366

Brief Title

Sodium Restriction in the Management of Cirrhotic Ascites

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Terminated

Why Stopped

Failure to recruit.

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ascites

Keywords

cirrhosis, portal hypertension, ascites, sodium restriction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

4 gram sodium diet

Arm Title

Arm Type

Active Comparator

Arm Description

2 gram sodium diet

Intervention Type

Other

Intervention Name(s)

Sodium restriction

Other Intervention Name(s)

No added salt diet

Intervention Description

4 gram sodium diet

Intervention Type

Other

Intervention Name(s)

Sodium restriction

Other Intervention Name(s)

Low sodium diet

Intervention Description

2 gram sodium diet

Primary Outcome Measure Information:

Title

Control of ascites

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Patient acceptance and compliance

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer A Cuthbert, M.D.

Organizational Affiliation

UT Southwestern Medical Center at Dallas

Official's Role

Study Director

Facility Information:

Facility Name

Parkland Memorial Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

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Sodium Restriction in the Management of Cirrhotic Ascites

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