Sodium Restriction in the Management of Cirrhotic Ascites

NCT00548366 | Terminated Phase 4

• 1 other identifier: UTSouthwestern 062007-066
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascites

Keywords

cirrhosis; portal hypertension; ascites; sodium restriction

Outcome Measures

Primary Outcomes (1)

• Control of ascites

  3 months

Secondary Outcomes (1)

• Patient acceptance and compliance

  3 months

Study Arms (2)

1

EXPERIMENTAL

4 gram sodium diet

Other: Sodium restriction

2

ACTIVE COMPARATOR

2 gram sodium diet

Other: Sodium restriction

Interventions

Sodium restriction OTHER

4 gram sodium diet

Also known as: No added salt diet

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Ascites; Fibrosis; Hypertension, Portal

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jennifer A Cuthbert, M.D.

  UT Southwestern Medical Center at Dallas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

US (1)