Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics
研究概览
简要总结
The question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. Therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. One hundred patients will be randomized into two groups. Group A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.
The percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two Groups of Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Grade 2 ascites
- •Serum creatinine less than 1.2 mtg/dl
- •Serum sodium > 130 mmol/l
- •Serum potassium within 3.5 and 4.5 mmol/l
- •At least five days after the withdrawal of diuretics
- •A 90 mmol/day Na diet.
排除标准
- •Any therapeutic paracentesis for ascites before inclusion
- •Cardiac or respiratory disease
- •Gastrointestinal bleeding, hepatic encephalopathy, bacterial infections in the last 4 weeks before inclusion.
- •The use of NSAIDs or other nephrotoxic drugs in the last 4 weeks before inclusion.
研究组 & 干预措施
A
干预措施: Spironolactone and furosemide (Drug)
B
干预措施: Spironolactone and furosemide (Drug)
结局指标
主要结局
the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics
时间窗: within three weeks
the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics
时间窗: within three weeks
次要结局
- time to get the response to diuretics(within three weeks)