Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-17 @ 11:11 PM
Study NCT ID:
NCT02866604
Status:
UNKNOWN
Last Update Posted:
2016-10-26
First Post:
2016-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052337', 'term': 'sterofundin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 days'}, {'measure': 'Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'Acid-base balance', 'timeFrame': '3 days', 'description': 'through out intervention period'}, {'measure': 'Daily mean change in intracranial pressure (ICP)', 'timeFrame': '3 days', 'description': 'through out intervention period'}, {'measure': 'Episodes of intracranial hypertension', 'timeFrame': '3 days', 'description': 'through out intervention period'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '3 days', 'description': 'through out intervention period'}, {'measure': 'Length of ICU stay', 'timeFrame': '30 days', 'description': 'through out intervention period'}, {'measure': 'electrolyte balance', 'timeFrame': '3 days'}, {'measure': 'ICU mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic brain injury', 'isotonic balanced fluid'], 'conditions': ['Brain Injuries']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the clinical outcomes of TBI patients receiving only Sterofundin or 0.9% saline as main fluid therapy.', 'detailedDescription': 'Study Design: Prospective single centre double-blind randomized controlled trial\n\nStudy endpoints/outcomes\n\nPrimary outcomes:\n\n* 30 day mortality\n* Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)\n\nSecondary outcomes:\n\n* Acid-base and electrolyte balance\n* Daily mean change in intracranial pressure (ICP)\n* Episodes of intracranial hypertension\n* Duration of mechanical ventilation\n* Length of ICU stay and ICU mortality\n\nStudy Duration: 2 years Site: UMMC. Departments involved: Emergency Medicine, Surgery, Anaesthesiology and Pharmacy\n\nMethodology. Investigators will assess patients admitted to the Emergency Department, UMMC, for eligibility.\n\nRandomisation:\n\nInvestigators will randomize patients in a 1:1 ratio to either 0.9% saline intravenous fluid group or Sterofundin® intravenous fluid group. An independent statistician not involved with the research will perform a block of eight randomisation using computerised number generator list.\n\nConduct of study The Department of Pharmacy will identically seal all 0.9% saline and Sterofundin® intravenous fluid bottles and label them, according to their type, as either A or B. The patients, investigators and medical and nursing staff will not be aware of the designation of the letters A and B to the fluids.\n\nInvestigators will administer the study fluid will immediately after patient randomisation and this will last for 72 hours.\n\nOther general care of the traumatic brain injury patients from both study arms will continue as per Neurosurgical Unit protocol and Brain Trauma Foundation guidelines.\n\nData handling\n\nInvestigators will collect all data relevant to both primary and secondary outcomes (see also attached proforma):\n\nStatistical analysis Investigators will conduct students t test, Chi squared and the Mann-Whitney U test as appropriate. Investigators will adjust results with univariable and multivariable logistic regression and report their odds ratio. Investigators will present survival analysis using Kaplan Meier curves and compare them using log rank test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age between 18 and 65 years of age\n* Non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) traumatic brain injury\n* Within 12 hours since the recorded time of injury\n\nExclusion Criteria:\n\n* Pregnancy\n* Polytrauma\n* Cardiac arrest at presentation\n* GCS of three with bilateral fixed dilated pupils,\n* Evidence of severe cardiac, respiratory, renal or liver dysfunction'}, 'identificationModule': {'nctId': 'NCT02866604', 'acronym': 'FLUID', 'briefTitle': 'Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)', 'orgStudyIdInfo': {'id': '201510-1766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Strerofundin', 'description': 'Days of intervention: 3 days', 'interventionNames': ['Procedure: Sterofundin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.9% saline', 'description': 'Days of intervention: 3 days', 'interventionNames': ['Procedure: 0.9% saline']}], 'interventions': [{'name': 'Sterofundin', 'type': 'PROCEDURE', 'armGroupLabels': ['Strerofundin']}, {'name': '0.9% saline', 'type': 'PROCEDURE', 'armGroupLabels': ['0.9% saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Petaling Jaya', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'contacts': [{'name': 'Sia S Fung, MSurg, PhD', 'role': 'CONTACT', 'email': 'sfsia02@um.edu.my', 'phone': '+603-79492441'}], 'facility': 'University of Malaya Medical Centre'}], 'centralContacts': [{'name': 'Sia S Fu, MSurg, PhD', 'role': 'CONTACT', 'email': 'sfsia02@um.edu.my', 'phone': '+603-79492441'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}