NL-OMON55418招募中4 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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Elective TIPS placement for refractory ascites or recurrent variceal
- •* 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
- •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
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 (main trunk)
- •7. Current or recent (<3 months) use of rifaximin
- •8. Overt neurologic diseases such as Alzheimer*s disease, Parkinson*s disease
- •9. Pregnant or breastfeeding women
- •10. Patients refusing or unable to sign informed consent
研究者
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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 trialpost-TIPS Hepatic Encephalopathy (HE)MedDRA version: 21.1Level: PTClassification code 10019660Term: Hepatic encephalopathySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10076204Term: Minimal hepatic encephalopathySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10066599Term: Hepatic encephalopathy prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10068826Term: Transjugular intrahepatic portosystemic shuntSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2018-004323-37-NLAcademic Medical Centre238
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