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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baqai Hospital, Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Frequency of MHE in Cirrhotic patients

Time frame: 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 outcomes

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

Time frame: 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

Time frame: 18 months

Short Form (SF)-36v2 Quality of Life Questionnaire will be used
Management of MHE currently in practice

Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

Dimension Research

Registry information

Acronym: Preempt

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Nov 25, 2015
Registry last updated: May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed