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

Completed

• Conditions: Hepatic Encephalopathy

• Registration Number: NCT02613858
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Primary Completion: 2017-03
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life (QoL) of patients at baselines	18 months	Short Form (SF)-36v2 Quality of Life Questionnaire will be used
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.
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

Trial Locations

Locations (6)

Baqai Hospital; 🇵🇰 Karachi, Pakistan

Doctor's Hospital; 🇵🇰 Lahore, Pakistan

Lady Reading Hospital; 🇵🇰 Peshawar, Pakistan

Fatima Memorial Hospital; 🇵🇰 Lahore, Pakistan

Jinnah Hospital Lahore; 🇵🇰 Lahore, Pakistan

Lahore General Hospital; 🇵🇰 Lahore, Pakistan