NCT00548366终止4 期
Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Control of ascites
研究概览
简要总结
To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.
Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.
详细描述
Secondary objectives:
- Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
- Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
- Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
- •Age 18-75
- •Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
- •Spanish-speaking subjects will be eligible for participation
排除标准
- •Active drug or alcohol abuse,
- •Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
- •Hemorrhagic ascites, malignant ascites,
- •Creatinine >2 mg/dL or CCl < 30 mL/min,
- •K > 5.5 mmol/L,
- •Diuretic refractory ascites
- •Allergy to or intolerance of either spironolactone or furosemide
- •Homelessness, incarceration, inability to follow up in clinic, or comply with diet.
结局指标
主要结局
Control of ascites
时间窗: 3 months
次要结局
- Patient acceptance and compliance(3 months)
研究者
研究点 (2)
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