跳至主要内容
临床试验/NCT04074473
NCT04074473Unknown4 期

Impact of Nonselective Beta-blocker on Acute Kidney Injury in Cirrhotic Patients With Esophageal Varices

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2015年4月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
170
试验地点
1
主要终点
Heparenal syndrome

研究概览

简要总结

We will include patients with EV and EVB. They will be randomized to EVL vs. NSBB for primary prevention And EVL+long-term NSBB vs. EVL+short-term NSBB for secondary prevention. 150 patients will be included in a 3-year period. Primary end-points are formation/progression of ascites, acute kidney injury and survival. The other outcomes such as bleeding, rebleeding, infection and other risk factors will be also analyzed.

详细描述

Despite advance in the prevention and treatment of esophageal variceal bleeding (EVB), it is still a majorcomplication of portal hypertension with the characteristic of a high mortality around 15~20% after anepisode of hemorrhage. Following development of EV and EVB, ascites and renal dysfunction occurs in a large portion of patients with time. The international consensus suggested use of non-selective beta-blocker(NSBB) to prevent EVB. Long-term use of NSBB was also found to decrease occurrence of encephalopathy and spontaneous bacterial peritonitis (SBP) and extend survival. Until 2010, Dr. Lebrec et al. found use of NSBB might decrease survival in cirrhotic patients with refractory ascites, therefore they suggested discontinued use of NSBB in these patients. The findings lead to a vigorous dispute between hepatologists. In 2011, the reputable team again found use of NSBB might cause post-paracentesis circulatory dysfunction (PPCD) in cirrhotic patients undergoing a large volume paracentesis. Occurrence of PPCD was known to cause acute kidney injury (AKI) and increase mortality. In 2014, Austria investigators found use of NSBB was associated with increased AKI and shortened survival in patients with SBP. Despite the findings of these studies implicated the harmful aspects of NSBB use, a major debate remained because lack of randomized controlled trial some unequal distribution of patients.Taipei Veterans General Hospital is renowned by its high profile research in portal hypertension and its related complications. The current proposal is aimed to clarify the strategy of NSBB use. We will include patients with EV and EVB. They will be randomized to EVL vs. NSBB for primary prevention And EVL+long-term NSBB vs. EVL+short-term NSBB for secondary prevention. 150 patients will be included in a 3-year period. Primary end-points are formation/progression of ascites, acute kidney injury and survival. The other outcomes such as bleeding, rebleeding, infection and other risk factors will be also analyzed.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 20 to 85 years
  • Cirrhotic patients with esophageal varices regardless of bleeding event or not will be enrolled in this study.

排除标准

  • Terminal stage HCC/ other malignancy/ Stroke or active sepsis/ Chronic kidney disease stage 4 under renal replacement therapy/ Contraindications to non-selective beta-blockers/ A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery/ Serum total bilirubin >10 mg/dL/ Refractory ascites/ Hepato-renal syndrome/ Pregnancy/ Severe heart failure (NYHA Fc III/IV)/ Bronchial asthma or chronic obstructive pulmonary disease/ Second or third degree atrioventricular block/ Severe hypotension/ Refusal to participate

研究组 & 干预措施

Propranolol alone

Placebo Comparator

TPropranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)

干预措施: propranolol (Drug)

Esophageal variceal ligation alone

Active Comparator

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.

干预措施: Esophageal varice ligation (Procedure)

Esophageal variceal ligation(DC inderal after EV eradication)

Experimental

Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.

干预措施: DC propranolol (Other)

结局指标

主要结局

Heparenal syndrome

时间窗: 3 years

overall survival

时间窗: 3 years

Acute kidney injury

时间窗: 3 years

次要结局

  • EV bleeding/rebleeding(3 years)
  • Infection rate(3 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验