跳至主要内容
临床试验/NCT00742339
NCT00742339终止2 期

Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome (HRS): An Open Multicentric Randomized Study

University of Padova1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2005年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
49
试验地点
1
主要终点
The primary end-point of the study is the complete reform of the renal function (serum creatinine < 1.5 mg/dl. The primary end point will be evaluated at the end of the treatment.

研究概览

简要总结

From 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the use of vasoconstrictors together with albumin in the treatment of this severe complication of portal hypertension in patients with cirrhosis is to correct the reduction of the effective circulating volume due to the splanchnic arterial vasodilatation.In most of these studies terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon, given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the 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

入选标准

  • Patients with cirrhosis and diagnosis of HRS type 1 or 2,serum creatinine > 2.5 mg/dl

排除标准

  • Diagnosis of HCC with a staging beyond the Milan Criteria di Milano
  • 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

Active Comparator

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 1.

干预措施: Terlipressin plus albumin (Drug)

2

Experimental

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 2.

干预措施: Midodrine plus octreotide plus human 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 (serum creatinine < 1.5 mg/dl. The primary end point will be evaluated at the end of the treatment.

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

研究者

发起方
University of Padova
申办方类型
Other

研究点 (1)

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