EUCTR2018-004323-37-NL进行中（未招募）1 期
Prevention of hepatic Encephalopathy by Administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt: a multi-centre randomized, double blind, placebo controlled trial. The PEARL trial - The PEARL trial
Academic Medical Centre0 个研究点目标入组 238 人开始时间: 2019年1月7日最近更新:
适应症
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
- 238
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.Elective TIPS placement for refractory ascites or recurrent variceal bleeding:
- •Recurrent tense ascites and one or more of the following criteria:
- •i.Not responding to the maximal dose of diuretics (400mg spironolactone and 160mg furosemide).
- •ii.Kidney insufficiency (Creatinine > 135 umol/L) induced by diuretics.
- •iii.Electrolyte disturbances (Sodium < 125 mmol/l, Potassium > 5.5 mmol/l) induced by diuretics.
- •iv.Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps).
- •(Recurrent) variceal bleeding, not responsive to treatment with endoscopic band ligation and/or beta-blockers, with a high risk of failure of endoscopic treatment:
- •i.Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis
- •ii.Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy
- •2.Age = 18 years
- •3.Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
- •4.Signed informed consent
- •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 226
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Any absolute contraindications for TIPS placement:
- •a.History of hepatic encephalopathy grade II-IV without precipitating factor
- •b.Heart failure NYHA = grade 3
- •c.Hepatocellular carcinoma (multifocal or large or centrally located)
- •d.Systemic infection / sepsis
- •e.Severe pulmonary hypertension
- •f.Unrelieved bile duct obstruction
- •g.Technically not feasible
- •h.Poor liver function (MELD score > 20)
- •2.Use of ciclosporin
- •3.Life-threating variceal bleeding with emergency TIPS placement
- •4.Age > 80 years
- •5.Non-cirrhotic portal hypertension
- •6.Portal vein thrombosis
- •7.Current or recent (<3 months) use of rifaximin
- •8.Overt neurologic diseases such as Alzheimer’s disease, Parkinson’s disease
- •10. Pregnant or breastfeeding women
- •11.Patients refusing or unable to sign informed consent
研究者
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