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

Hepatic Encephalopathy Clinical Trial

— Preempt  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613858
• Other study ID #: EPIDI038
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: May 10, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Locations

Country	Name	City	State
Pakistan	Baqai Hospital	Karachi
Pakistan	Doctor's Hospital	Lahore
Pakistan	Fatima Memorial Hospital	Lahore
Pakistan	Jinnah Hospital Lahore	Lahore
Pakistan	Lahore General Hospital	Lahore
Pakistan	Lady Reading Hospital	Peshawar

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Dimension Research

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	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.	18 months
Secondary	Quality of Life (QoL) of patients at baselines	Short Form (SF)-36v2 Quality of Life Questionnaire will be used	18 months
Secondary	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	18 months