A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- mortality in short, median and long term
研究概览
简要总结
The study analyzes the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predicts risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
详细描述
Hepatic encephalopathy (HE) is a common complication and one of the most serious manifestations of cirrhosis and acute on chronic liver failure, not only increasing the risks of death, but also seriously affecting the lives of the patients and their caregivers. Minimal hepatic encephalopathy (MHE), the earliest stage of HE, despite its undiscernible clinical evidence, it is related with abnormalities of patients' daily cognition, emotion, muscular strength, driving ability, quality of life and socioeconomic status At present. However, MHE is not easy to diagnose in daily clinical work because of time-consuming psychometric tests, especially the inconvenience of application in weak inpatients. This study aims to analyze the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predict risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
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
- •>18 years old
- •cirrhosis
- •acute on chronic liver failure
排除标准
- •(1) status of OHE; (2) accompanying nervous system diseases, such as dementia or stroke; (3) a history of recent head trauma or surgery, and (4) organic lesions in the brain, such as haemorrhages or infarction; (5) inability to finish the psychometric hepatic encephalopathy score (PHES), such as unable to observe patterns or words clearly on paper, and (6) a recent transjugular intrahepatic portosystemic shunt (TIPS) or abdominal imaging demonstrated portosystemic shunts, and (7) high alcohol consumption (> 30 g/day in men or 20 g/day in women) or psychoactive medication consumption in the past four weeks.
结局指标
主要结局
mortality in short, median and long term
时间窗: 30 and 90 days, 1, 2, 3 years
mortality in 30 days, 90 days, 1 year, 2 years, 3 years
progression of 2-4 HE
时间窗: 30 days
Incidence of HE progression (2/3/4 HE)
次要结局
未报告次要终点
研究者
Qin Ning
Director of Department of Infectious Diseases
Tongji Hospital