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

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

This study has been completed.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00006166

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 III

MedlinePlus related topics:

Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label

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

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

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

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

More Information

Study ID Numbers:	NASTRA, 1R01DK51523
First Received:	August 8, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006166
Health Authority:	United States: Federal Government

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

refractory ascites

paracenteses

Study placed in the following topic categories:

Liver Diseases

Digestive System Diseases

Fibrosis

Ascites

Liver Cirrhosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 06, 2008