Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00006166
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
North American Study for the Treatment of Refractory Ascites (NASTRA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], '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'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2001-10'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2000-08-08', 'studyFirstSubmitQcDate': '2000-08-08', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-08-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['refractory ascites', 'paracenteses'], 'conditions': ['Ascites', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH\n* Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND\n* Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)\n\nExclusion Criteria:\n\n* Causes of ascites other than cirrhosis and portal hypertension\n* Terminal liver failure\n* Portal vein thrombosis\n* Congestive heart failure\n* Acute renal failure\n* Active encephalopathy\n* Alcoholic hepatitis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00006166', 'briefTitle': 'North American Study for the Treatment of Refractory Ascites (NASTRA)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial', 'orgStudyIdInfo': {'id': 'NASTRA (completed)'}, 'secondaryIdInfos': [{'id': '1R01DK051523', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK051523', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Transjugular intrahepatic portasystemic shunts (TIPS)', 'type': 'PROCEDURE'}, {'name': 'Total paracentecis (TP)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136-1038', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '68198-2000', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '23298-0711', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medical College of Virginia Hospitals', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Toronto Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}