Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-29 @ 5:57 AM
Study NCT ID:
NCT00548366
Status:
TERMINATED
Last Update Posted:
2010-09-14
First Post:
2007-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Restriction in the Management of Cirrhotic Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'whyStopped': 'Failure to recruit.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-10', 'studyFirstSubmitDate': '2007-10-22', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Control of ascites', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Patient acceptance and compliance', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cirrhosis', 'portal hypertension', 'ascites', 'sodium restriction'], 'conditions': ['Ascites']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary 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.', 'detailedDescription': 'Secondary objectives:\n\n1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet\n2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet\n3. 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,\n* Age 18-75\n* Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites\n* Spanish-speaking subjects will be eligible for participation\n\nExclusion Criteria:\n\n* Active drug or alcohol abuse,\n* Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,\n* Hemorrhagic ascites, malignant ascites,\n* Creatinine \\>2 mg/dL or CCl \\< 30 mL/min,\n* K \\> 5.5 mmol/L,\n* Diuretic refractory ascites\n* Allergy to or intolerance of either spironolactone or furosemide\n* Homelessness, incarceration, inability to follow up in clinic, or comply with diet.'}, 'identificationModule': {'nctId': 'NCT00548366', 'briefTitle': 'Sodium Restriction in the Management of Cirrhotic Ascites', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites', 'orgStudyIdInfo': {'id': 'UTSouthwestern 062007-066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '4 gram sodium diet', 'interventionNames': ['Other: Sodium restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2 gram sodium diet', 'interventionNames': ['Other: Sodium restriction']}], 'interventions': [{'name': 'Sodium restriction', 'type': 'OTHER', 'otherNames': ['No added salt diet'], 'description': '4 gram sodium diet', 'armGroupLabels': ['1']}, {'name': 'Sodium restriction', 'type': 'OTHER', 'otherNames': ['Low sodium diet'], 'description': '2 gram sodium diet', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jennifer A Cuthbert, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UT Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jennifer Cuthbert', 'oldOrganization': 'UT Southwestern Medical Center at Dallas'}}}}