NCT01530711Unknown4 期
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
Pere Gines6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Changes in arterial pressure and creatinine
研究概览
简要总结
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatorenal syndrome type
- •Signed informed consent.
- •No exclusion criteria.
- •At least 18 years old
- •Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.
排除标准
- •Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
- •Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
- •Cardiac or respiratory failure clinically significant.
- •Clinically significant peripheral artery disease.
- •A history of ischemic heart disease.
- •Hypersensitivity to terlipressin and / or albumin or any of the excipients.
- •Pregnancy.
- •Septic shock.
- •Chronic renal failure.
- •Women in lactation
研究组 & 干预措施
terlipressin
Experimental
干预措施: Terlipressin and albumin (Drug)
结局指标
主要结局
Changes in arterial pressure and creatinine
时间窗: 4 months
次要结局
- Hepatorenal Syndrome reversion due to hemodynamic changes.(4 months)
- Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.(4 months)
- Treatment-related adverse events(4 months)
研究者
Pere Gines
MD, PhD
Hospital Clinic of Barcelona
研究点 (6)
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