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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006166
• Other study ID #: NASTRA (completed)
• Secondary ID: 1R01DK051523
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2000
• Last updated: January 12, 2010
• Start date: March 1997
• Est. completion date: October 2001

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Procedure:
• Transjugular intrahepatic portasystemic shunts (TIPS)

• Total paracentecis (TP)

Locations

Country	Name	City	State
Canada	The Toronto Hospital	Toronto	Ontario
United States	University of Miami Hospital	Miami	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Oregon Health Sciences University	Portland	Oregon
United States	Medical College of Virginia Hospitals	Richmond	Virginia
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada,