Hepatic Encephalopathy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Dimension Research
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of MHE in Cirrhotic patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis | 18 months | Odds Ratios (OR) and their 95% Confidence Intervals (CI) will be estimated using Logistic Regression. The likelihood ratio test used to assess the association between the explanatory variables and the risk of the MHE. Invariable analyses will perform to examine the effect of each variable on the risk of MHE. In multivariate analysis all insignificant variables (p \>0.05) will check for their confounding and interaction effects before their removal from the final model. |
| Quality of Life (QoL) of patients at baselines | 18 months | Short Form (SF)-36v2 Quality of Life Questionnaire will be used |
| Management of MHE currently in practice | 18 months | As per practice of the physician/Investigator. Management of MHE will be recorded. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency |
Countries
Pakistan
Outcome results
None listed