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临床试验/NCT03144713
NCT03144713已完成不适用

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

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年5月28日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

Midodrine 7.5 mg thrice daily for 3 days.

干预措施: Midodrine (Drug)

Standard Medical Therapy

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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