NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The primary end point of the study was serum creatinine less than 1.5 mg
研究概览
简要总结
Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
- •Absence of shock, fluid losses and treatment with nephrotoxic drug
- •No improvement in renal function following diuretic withdrawal and plasma volume expansion
- •No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour
排除标准
- •Patients with history of coronary artery disease
- •Cardiomyopathy
- •Ventricular arrhythmia
- •Obstructive arterial disease of limbs -
研究组 & 干预措施
Terlipressin and Type-2 HRS
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour.
干预措施: Noradrenaline (Drug)
Terlipressin and Type-2 HRS
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour.
干预措施: Terlipressin (Drug)
Noradrenaline and Type-2 HRS
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
干预措施: Noradrenaline (Drug)
Noradrenaline and Type-2 HRS
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
干预措施: Terlipressin (Drug)
结局指标
主要结局
The primary end point of the study was serum creatinine less than 1.5 mg
时间窗: 15 days
次要结局
- Secondary end points include death of patients(15 days)
研究者
Arun Sharma
Clinical Professor
Post Graduate Institute of Medical Education and Research, Chandigarh