Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
研究概览
简要总结
- Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.
- Study Design: Prospective Open Labeled Randomized Controlled Trial.
- Study Period: January 2017 to December 2017
- Intervention- Subjects will be randomized to 3 groups
- All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only
- Monitoring and Assessment: Clinical evaluation will be done at regular intervals.
- Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.
- Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)
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
- •Patients with cirrhosis who undergo Large volume paracentesis (> 5L)
- •Patients with age from 18-75 years
排除标准
- •Renal failure ( Creatinine>1.5mg/dl)
- •Recent Gastrointestinal bleeding within 7 days
- •Spontaneous bacterial Peritonitis
- •Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
- •Systemic arterial hypertension ( >160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
- •Patients with active untreated sepsis
- •Patients with hepatic encephalopathy
- •No use of drugs affecting systemic hemodynamic 3 days prior to enrollment
- •Refusal to participate
研究组 & 干预措施
Terlipressin
Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
干预措施: Terlipressin (Drug)
Midodrine
Midodrine 7.5 mg thrice daily for 3 days.
干预措施: Midodrine (Drug)
Standard Medical Therapy
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
干预措施: Albumin (Drug)
结局指标
主要结局
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
时间窗: Day 6
次要结局
- Number of hospital admission withing 28 days in all the 3 groups(28 days)
- Recurrence of ascites in all the 3 groups(Day 28)
- Development of Acute Kidney Injury in all the 3 groups(Day 28)
- Survival in all the 3 groups(Day 28)
- Development of Hyponatremia in all the 3 groups(Day 28)
- Development of Hepatic Encephalopathy in all the 3 groups(Day 28)
