Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Time to Recurrence of Ascites.
研究概览
简要总结
This clinical trial compares a combination of two drugs that constrict blood vessels (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.
详细描述
This prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. Measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of any etiology
- •Age 18-80 years
- •Moderate to severe ascites
排除标准
- •No or small ascites
- •Severe hepatic hydrothorax
- •Recent GI (gastrointestinal) hemorrhage
- •Active bacterial infection
- •Cardiac failure
- •Organic renal disease
- •Hepatocellular carcinoma
- •Severe comorbidity (advanced neoplasia)
- •Serum creatinine > 3 mg/dl
- •Pregnancy
研究组 & 干预措施
Albumin (Control group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
干预措施: Albumin (Drug)
Albumin (Control group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
干预措施: Oral tablet (Midodrine placebo) (Drug)
Albumin (Control group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
干预措施: Saline injection (Octreotide LAR placebo) (Drug)
Albumin (Control group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
干预措施: Large Volume Paracentesis (Procedure)
Vasoconstrictor (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
干预措施: Intravenous Saline Infusion (Albumin placebo) (Drug)
Vasoconstrictor (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
干预措施: Midodrine (Drug)
Vasoconstrictor (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
干预措施: Octreotide LAR (Drug)
Vasoconstrictor (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
干预措施: Large Volume Paracentesis (Procedure)
结局指标
主要结局
Time to Recurrence of Ascites.
时间窗: Variable depending on the patient, average 10 days
Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
次要结局
- Development of Post-paracentesis Circulatory Dysfunction (PCD)(6 days after paracentesis)