NCT00006166已完成3 期
The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)12 个研究点 分布在 2 个国家开始时间: 1997年3月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究者
研究点 (12)
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