A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 41
- 主要终点
- Incidence of hepatic encephalopathy
研究概览
简要总结
Patients with decompensated liver cirrhosis are mostly managed in Internal Medicine outpatient clinics and wards; among these patients, overt hepatic encephalopathy represents one of the most frequent causes of emergency hospital admission. Furthermore, hospitalizations for decompensated cirrhosis are expected to increase steadily, given the progressive rise in chronic liver diseases of metabolic and alcohol-related origin. Therefore, the skills of the Internal Medicine physician must increasingly include screening for minimal hepatic encephalopathy, identification and treatment of overt hepatic encephalopathy, and prevention of relapses.
In view of the lack of data from prospective studies on the incidence, management, and outcomes of hepatic encephalopathy in patients admitted to Internal Medicine wards in Italy, it is considered important to collect and analyze a large case series in order to identify critical issues in management during hospitalization and at discharge, also with the aim of preventing rehospitalizations.
On this basis, Fondazione FADOI has decided to promote the FADOI-HEPTAGON study, a prospective, multicenter, observational study involving approximately 45 Internal Medicine Units across Italy, which will competitively enroll at least 400 consecutive inpatient cases of liver cirrhosis over a one-year period, collecting data on management, treatment, and clinical outcomes during the acute phase and at 3 and 9 months after discharge (follow-up). Among these subjects, patients with hepatic encephalopathy will also be identified in order to assess its incidence.
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
- 否
入选标准
- •Age ≥18 years
- •Signed informed consent
- •Diagnosis of liver cirrhosis according to recognized clinical, laboratory, and imaging criteria and/or evidence of portal hypertension or liver stiffness ≥ 20 kPa.
排除标准
- •Patient enrolled in other non-observational clinical trials
结局指标
主要结局
Incidence of hepatic encephalopathy
时间窗: through study completion, an average of 1 year
Incidence of both minimal and overt hepatic encephalopathy in patients with liver cirrhosis
次要结局
- Rate of screening for minimal hepatic encephalopathy(through study completion, an average of 1 year)
- Rates of in-hospital mortality(from the the discharge untill 9 months)
- Readmission rates(from the the discharge untill 9 months)
- Rates of counseling(at discharge)
- Description of the treatments for overt hepatic encephalopathy(through study completion, an average of 1 year)