Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT02940834
Status:
UNKNOWN
Last Update Posted:
2016-10-21
First Post:
2016-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-20', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports', 'timeFrame': 'first 10 days after admission in icu or discharge whichever is earlier'}], 'secondaryOutcomes': [{'measure': 'predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data', 'timeFrame': 'first 10 days after admission in icu or discharge whichever is earlier'}, {'measure': 'relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically', 'timeFrame': '1st and 3rd month after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sodium Imbalance in Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Observational study about prevalence, predictors of sodium imbalance and prognostic significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult and paediatric patients with isolated head injury\n\nExclusion Criteria:\n\n* age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma'}, 'identificationModule': {'nctId': 'NCT02940834', 'briefTitle': 'Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre', 'orgStudyIdInfo': {'id': 'Na TBI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with sodium imbalance'}, {'label': 'patients without sodium imbalance'}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'DR NIDHI PANDA, MD ANAESTHESIA', 'role': 'CONTACT', 'email': 'nidhibp@gmail.com', 'phone': '7087009525', 'phoneExt': '+91'}], 'facility': 'Post Graduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'DR NIDHI PANDA, MD ANAESTHESIA', 'role': 'CONTACT', 'email': 'nidhibp@gmail.com', 'phone': '7087009525', 'phoneExt': '+91'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'DR GANESH ADAIKKALAVAN M', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}