North American Study for the Treatment of Refractory Ascites (NASTRA)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006166
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Ascites
Liver Cirrhosis
Procedure: Transjugular intrahepatic portasystemic shunts (TIPS)
Procedure: Total paracentecis (TP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: March 1997
Estimated Study Completion Date: October 2001
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH
  • Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND
  • 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)

Exclusion Criteria:

  • Causes of ascites other than cirrhosis and portal hypertension
  • Terminal liver failure
  • Portal vein thrombosis
  • Congestive heart failure
  • Acute renal failure
  • Active encephalopathy
  • Alcoholic hepatitis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006166

Locations
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136-1038
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2000
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Virginia
Medical College of Virginia Hospitals
Richmond, Virginia, United States, 23298-0711
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98105
Canada, Ontario
The Toronto Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006166     History of Changes
Other Study ID Numbers: NASTRA (completed), 1R01DK51523
Study First Received: August 8, 2000
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
refractory ascites
paracenteses

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014