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临床试验/NCT03633812
NCT03633812Unknown不适用

The Effect of Preoperative Beta Blocker Use on Intraoperative Hemodynamics and Postoperative Renal Function in End-stage Liver Disease Patients Undergoing Liver Transplantation

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 477 人开始时间: 2016年10月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
477
试验地点
2
主要终点
Acute kidney injury

研究概览

简要总结

This is prospective cohort study of patients classified by the premedication history of beta-blocker. The investigators aim to evaluate the hemodynamic effect of beta blocker through Swan-Ganz catheter monitoring and arterial pressure waveform analysis during surgery. The investigators also plan to observe the long-term effects of beta blocker on acute renal failure, allograft failure and mortality.

详细描述

Since beta blockers have been shown to reduce portal venous pressure in 1980, the nonselective beta blocker (NSBB) has been widely used for the last 25 years as the primary treatment for portal hypertension. NSBB, such as propranolol and nadolol, has been shown to reduce cardiac output through β1 -receptor block and to constrict visceral vessels via β2-receptor block, thereby lowering portal venous pressure in patients with chronic liver disease. NSBB contributed to reducing complications such as esophageal variceal bleeding, ascites, hepatic encephalopathy, and improving survival in patients with cirrhosis. In addition, the use of NSBB in patients with ascites has been demonstrated to reduce the digestion time of intestinal food and reduce bacterial migration into the abdominal cavity and bloodstream.

On the other hand, recent studies have shown that NSBB use in the patients with advanced cirrhosis (accompanied by refractory ascites, spontaneous peritonitis, severe alcoholic hepatitis) may increase circulatory failure, acute renal failure, and mortality. When the cardiac index was less than 1.5 L / min / m² or the mean blood pressure was less than 80 mmHg in advanced cirrhosis with ascites, 1-year survival rate was found to be about 30% lower than the control. The use of beta blockers is argued to be avoided in the cirrhotic patients with refractory ascites because the mortality rate of these patients is associated with the use of beta blockers. These studies have been questioned in terms of reliability of the setting of treatment and control groups and correction of disturbance variables.

The window hypothesis has received attention for the risk-benefit of NSBB. This means that the beta blocker may be beneficial or harmful to the cirrhotic patients depending on the stage of disease progression. In conclusion, the use of beta-blockers in patients with early cirrhosis without moderate to large varix has no effect on prevention of esophageal varices, but is associated with depression, tiredness, sexual dysfunction, decreased cardiac output, increased risk of heart failure, symptomatic bradycardia, increased airway resistance, and bronchospasm. As the cirrhosis progresses, many changes occur in the cardiovascular system. The sympathetic nervous system and resin-angiotensin-aldosterone axis are up-regulated to compensate for the lack of effective blood volume due to peripheral vascular relaxation and hypotension. It is believed that the use of beta-blockers at this time may improve survival by reducing esophageal bleeding and bacterial migration. If the liver cirrhosis progresses more, the use of beta-blockers may compromise cardiac output, blood pressure, perfusion to important organs, thereby increasing the incidence of hepatorenal syndrome and mortality. The use of beta-blockers seems to be beneficial between the point of moderate to large varix generation to the point of advanced cirrhosis with undesired hemodynamic effect (spontaneous ascites, hepatorenal syndrome, spontaneous bacterial peritonitis, sepsis). The research is still ongoing and controversial.

As mentioned earlier, the use of beta blockers in patients with liver disease has been actively studied for the last 10 years, but most studies have been done in patients waiting for liver transplantation. Research is minimal in patients who actually undergo liver transplantation. In addition, studies have shown that beta blockers increase survival in patients waiting for liver transplantation by lowering portal venous pressure through beta 1, 2 -receptor block. But the actual research of preoperative beta blocker on perioperative hemodynamics, postoperative complications, and mortality is still lacking.

This is prospective cohort study of patients classified by the premedication history of beta-blocker. The investigators aim to evaluate the hemodynamic effect of beta blocker through Swan-Ganz catheter monitoring and arterial pressure waveform analysis during surgery. The investigators also plan to observe the long-term effects of beta blocker on acute renal failure, allograft failure and mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • living donor liver transplantation recipients

排除标准

  • previous history of acute kidney injury
  • previous liver transplantation history
  • Fulminant hepatic failure
  • history of TIPS, transjugular intrahepatic porto-systemic shunt

结局指标

主要结局

Acute kidney injury

时间窗: 1 week

Creatinine change

次要结局

  • Graft failure(1 year)
  • Mortality(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Gol Song

Professor

Asan Medical Center

研究点 (2)

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