NCT02613858已完成不适用
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 550
- 试验地点
- 6
- 主要终点
- Frequency of MHE in Cirrhotic patients
研究概览
简要总结
The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria.
- •Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL).
- •Patients willing to provide written authorization to provide data for the study.
排除标准
- •Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.
结局指标
主要结局
Frequency of MHE in Cirrhotic patients
时间窗: 18 months
Continuous variables with normal and non-normal distributions would be reported as mean (SD) and median \[inter-quartile range (IQR)\], respectively. Prevalence of MHE in cirrhotic patients with 95% confidence Interval (CI) will be calculated. Continuous variables between group will compared by using Independent sample t test, and categorical variables will compare by using the chi-square test.
次要结局
- Quality of Life (QoL) of patients at baselines(18 months)
- The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis(18 months)
- Management of MHE currently in practice(18 months)
研究者
研究点 (6)
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