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

Tracking Information
First Received Date ^ICMJE	August 8, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 1997
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	North American Study for the Treatment of Refractory Ascites (NASTRA)
Official Title ^ICMJE	The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label
Condition ^ICMJE	Ascites Liver Cirrhosis
Intervention ^ICMJE	Procedure: Transjugular intrahepatic portasystemic shunts (TIPS) Procedure: Total paracentecis (TP)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	October 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00006166
Responsible Party
Study ID Numbers ^ICMJE	NASTRA, 1R01DK51523
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	May 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP