Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quantification of middle cerebral artery resistive index
研究概览
简要总结
Minimal hepatic encephalopathy (MHE) is a subclinical complication of liver cirrhosis with a relevant social impact. Thus, there is urgent need to implement easy to use diagnostic tools for the early identification of affected patients.
This study was aimed to investigate cerebral blood flow, systemic hemodynamics as well as endothelial function of cirrhotic patients with MHE, and to verify their change after treatment with rifaximin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of liver cirrhosis on the basis of clinical, laboratory and ultrasound findings
排除标准
- •active alcohol abuse (excessive alcohol intake stopped more than 6 months before the enrollment);
- •chronic pulmonary diseases; ongoing infections; cerebrovascular diseases; primary or secondary cerebral neoplasm; primary liver neoplasm; heart function failure; chronic kidney disease; peripheral vascular disease; treatment with rifaximin or systemic antibiotics in the previous 15 days;
- •smoking habit;
- •grade 1 or overt hepatic encephalopathy.
研究组 & 干预措施
Cirrhosis MHE
Patients with liver cirrhosis with minimal hepatic encephalopathy
干预措施: Rifaximin (Drug)
结局指标
主要结局
Quantification of middle cerebral artery resistive index
时间窗: baseline
Quantification of middle cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Quantification of middle cerebral artery pulsatility index
时间窗: baseline
Quantification of middle cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in posterior cerebral artery pulsatility index after treatment with rifaximin
时间窗: at the end of rifaximin treatment (15 days)
Variation of posterior cerebral artery pulsatility index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE
Quantification of posterior cerebral artery resistive index
时间窗: baseline
Quantification of posterior cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in middle cerebral artery pulsatility index after treatment with rifaximin
时间窗: at the end of rifaximin treatment (15 days)
Variation of middle cerebral artery pulsatility index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE
Quantification of posterior cerebral artery pulsatility index
时间窗: baseline
Quantification of posterior cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in middle cerebral artery resistive index after treatment with rifaximin
时间窗: at the end of rifaximin treatment (15 days)
Variation of middle cerebral artery resistive index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE
Change in posterior cerebral artery resistive index after treatment with rifaximin
时间窗: at the end of rifaximin treatment (15 days)
Variation of posterior cerebral artery resistive index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE
次要结局
- Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without(baseline)
- Change in renal artery resistive index after treatment with rifaximin(at the end of rifaximin treatment (15 days))
- Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without(baseline)
- Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without(baseline)
- Change in splenic artery resistive index after treatment with rifaximin(at the end of rifaximin treatment (15 days))
- Change in flow mediated dilation after treatment with rifaximin(at the end of rifaximin treatment (15 days))
研究者
Francesca Ponziani
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS