Terlipressin Given As I.V. Boluses Vs Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome (Hrs): Preliminary Results Of A Randomized Controlled Clinical Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl).
研究概览
简要总结
It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.
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 and type 1 HRS
排除标准
- •HCC beyond the Milan Criteria,septic shock (systolic arterial pressure < 90 mmHg,
- •Significant heart or respiratory failure,
- •Peripheral arteriophaty clinically significant,
- •Previous heart stroke or significant alteration of the ECG
研究组 & 干预措施
1
35 patients with cirrhosis and type 1 HRS
干预措施: terlipressin given by intravenous boluses and albumin (Drug)
2
35 patients with cirrhosis and type 1 HRS
干预措施: terlipressin given by continuous intravenous infusion and albumin (Drug)
结局指标
主要结局
The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl).
时间窗: The treatment will be continued for a maximum of 15 days
次要结局
未报告次要终点