NCT04353193Unknown4 期
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Juan A. Arnaiz1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年6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
- 36
- 试验地点
- 1
- 主要终点
- Change in HVPG
研究概览
简要总结
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver 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
- Single (Participant)
盲法说明
single blind
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
- •Age: 18-75 years old.
- •Liver Cirrhosis
- •Portal hypertension
- •Stable disease in the absence of vasoactive agents
- •Signed informed consent form
排除标准
- •Patients on medications that can prolong QT interval
- •Patients with HCC not fulfilling Milan criteria for transplant
- •Grade II-IV hepatic encephalopathy
- •GI bleeding in the last 10 days
- •Child-Pugh C above 12 points
- •Bacterial infection in the last 10 days
- •HVPG <12mmHg
- •Plasma sodium <130mmol/l
- •Serum creatinine >2mg/dl
- •Serum bilirubin >5mg/dl
- •Uncontrolled cardiovascular disease
- •HIV infection
- •Extra hepatic malignancies
- •Heart failure NYHA Grade III/IV, COPD GOLD>2
- •Morbid obesity
- •Coronary heart disease or intestinal ischemia
- •Pregnancy or breastfeeding
研究组 & 干预措施
Terlipressin IV bolus
Experimental
Terlipressin 1mg IV bolus
干预措施: Terlipressin (Drug)
Terlipressin IV continuous infusion
Experimental
Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
干预措施: Terlipressin (Drug)
Octreotide IV bolus plus continuous infusion
Experimental
Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
干预措施: Octreotide (Drug)
结局指标
主要结局
Change in HVPG
时间窗: 30 minutes, 1 hour and 2 hours
次要结局
未报告次要终点
研究者
Juan A. Arnaiz
MD
Hospital Clinic of Barcelona
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Hemodynamic Effects of Terlipressin and High Dose OctreotideGastric and Esophageal VaricesNCT02119884Shanghai Zhongshan Hospital88
进行中（未招募）
1 期
Clinical trial to compare the administration of a single dose of two different medicines in patients with hepatic cirrhosis and portal hypertension.EUCTR2019-004328-39-ESFundació Clínic per a la Recerca Biomèdica_FCRB36
Unknown
不适用
Effects of Terlipressin When Usual Somatostatin or Octreotide Dose FailsEsophageal and Gastric VaricesHemorrhageLiver CirrhosisNCT02311608Shanghai Zhongshan Hospital1,320
已完成
4 期
The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal BleedPortal HypertensionHematemesisMelenaCirrhosisNCT00534677Aga Khan University320
已完成
2 期
Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary SurgeryHemodynamics, Liver, TerlipressinNCT02718599Assiut University50