EUCTR2019-004328-39-ES进行中（未招募）1 期
Hemodynamic profile of terlipressin and octreotide in patients with cirrhosis and portal hypertension. A randomised, single blinded clinical trial. - INFUTER
Fundació Clínic per a la Recerca Biomèdica_FCRB0 个研究点目标入组 36 人开始时间: 2020年2月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age 18-75 years old.
- •2.Liver cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included.
- •3.Child-Pugh B patients or Child-Pugh C patients (up to 12 points).
- •4.Portal hypertension (defined as HVPG =12mmHg, confirmed during hepatic vein catheterisation)
- •5.Stable disease in the absence of vasoactive agents
- •6.Signed informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1.Patients on medications that can prolong the QT interval, a prior history of QT prolongation or on any medication with a known risk of QT prolongation and Torsade de Pointes.
- •2.Morbid obesity
- •3.Prior history of cardiovascular disease including ischemic heart disease or intestinal ischemia.
- •4.Plasma sodium <130mmol/l
- •5.Serum creatinine =2 mg/dL (176.8 µmol/L).
- •6.Serum bilirubin>5 mg/dL (85.5 µmol/L).
- •7.INR =2.5.
- •8.Bacterial infection within 10 days before study inclusion.
- •9.Gastrointestinal bleeding within 10 days before study inclusion.
- •10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
- •11.Child-Pugh C patients (= 12 points).
- •12.Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria. (Patients with HCC not fulfilling Milan criteria for liver transplant)
- •13.HIV infection.
- •14.Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- •15.Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.
- •16.Pregnancy or breastfeeding.
- •17.Patients included in other clinical trials in the month before inclusion.
- •18.Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- •19.Refusal to give informed consent.
研究者
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