Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan

Abbott550 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

Hepatic Encephalopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

Baqai Hospital

Karachi, Pakistan

Fatima Memorial Hospital

Lahore, Pakistan

Lahore General Hospital

Lahore, Pakistan

Jinnah Hospital Lahore

Lahore, Pakistan

Outcomes

Primary Outcomes

Frequency of MHE in Cirrhotic patients

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.

Time frame: 18 months

Secondary Outcomes

The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis

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.

Time frame: 18 months

Quality of Life (QoL) of patients at baselines

Short Form (SF)-36v2 Quality of Life Questionnaire will be used

Time frame: 18 months

Management of MHE currently in practice

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

Time frame: 18 months

Data from ClinicalTrials.gov

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