Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02613858
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2015-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of MHE in Cirrhotic patients', 'timeFrame': '18 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'Quality of Life (QoL) of patients at baselines', 'timeFrame': '18 months', 'description': 'Short Form (SF)-36v2 Quality of Life Questionnaire will be used'}, {'measure': 'Management of MHE currently in practice', 'timeFrame': '18 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic/Private Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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).\n* Patients willing to provide written authorization to provide data for the study.\n\nExclusion Criteria:\n\n* Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.'}, 'identificationModule': {'nctId': 'NCT02613858', 'acronym': 'Preempt', 'briefTitle': 'Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'orgStudyIdInfo': {'id': 'EPIDI038'}}, 'contactsLocationsModule': {'locations': [{'zip': '74700', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Baqai Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54000', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Fatima Memorial Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Lahore General Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54550', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Jinnah Hospital Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54770', 'city': 'Lahore', 'country': 'Pakistan', 'facility': "Doctor's Hospital", 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '25000', 'city': 'Peshawar', 'country': 'Pakistan', 'facility': 'Lady Reading Hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Raeefuddin Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director, Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dimension Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}