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

January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Study Completion

October 1, 2001

Study Registration Dates

First Submitted

August 8, 2000

First Submitted That Met QC Criteria

August 8, 2000

First Posted (Estimate)

August 9, 2000

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASTRA (completed)
  • 1R01DK051523 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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