Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

Hospital Clinic of Barcelona2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2002年2月最近更新: 2007年4月11日

适应症

试验速览

阶段: 4 期
状态: 暂停
发起方: Hospital Clinic of Barcelona
入组人数: 100
试验地点: 2
主要终点: Survival

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

详细描述

Phase 3

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
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 HRS type 1 or 2 with serum creatinine >2 mg/dL
•Age between 18 and 75 years
•Written informed consent.
•Absence of exclusion criteria

排除标准

•Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
•Active infection with systemic inflammatory response syndrome
•Respiratory or cardiac dysfunction.
•Arteriopathy.
•Ischemic cardiopathy.
•Arterial hypertension ( >140/90 mmHg during hospitalization )

结局指标

主要结局

Survival

次要结局

未报告次要终点

研究者

发起方

Hospital Clinic of Barcelona

申办方类型

Other

研究点 (2)

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