Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT06940258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'A vascular US expert will read the number contained in computer generated randomization software and determine group assignments. Daily; he will be responsible on prescribing of the required fluid.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After enrollment, patients will be randomly allocated using block into two groups of 46 patients in each group; ultrasound-guided fluid management (US group) or standard care (C group)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fluid balance', 'timeFrame': 'after 96 hours from the admission', 'description': 'the difference between fluid input and fluid loss'}], 'secondaryOutcomes': [{'measure': 'Urine output', 'timeFrame': 'Daily for 7 weeks', 'description': 'mL'}, {'measure': 'Central Venous Pressure (CVP) measurements', 'timeFrame': 'Daily every 6 hours for 7 days', 'description': 'cm H2O'}, {'measure': 'Frequency and duration of hypotension', 'timeFrame': 'within first 7 days', 'description': 'systolic blood pressure less than 90 mmhg'}, {'measure': 'Glasgow Coma Scale', 'timeFrame': 'daily within first 7 days', 'description': 'range from 3-to-15'}, {'measure': 'Central capillary refill', 'timeFrame': 'Daily for 7 days', 'description': 'seconds'}, {'measure': 'incidence of pulmonary edema', 'timeFrame': 'Daily within first 7 days', 'description': 'new B-lines in lung Ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caval aorta index', 'traumatic brain injury'], 'conditions': ['Fluid Balance']}, 'descriptionModule': {'briefSummary': 'Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.', 'detailedDescription': 'The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).\n\nIn this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTraumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4\n\nExclusion Criteria:\n\nInability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days'}, 'identificationModule': {'nctId': 'NCT06940258', 'acronym': 'CAI for fluids', 'briefTitle': 'Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Caval aorta index'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: control group']}, {'type': 'EXPERIMENTAL', 'label': 'ultrasound-guided caval-aorta index group', 'interventionNames': ['Procedure: ultrasound measurement of caval aorta index']}], 'interventions': [{'name': 'ultrasound measurement of caval aorta index', 'type': 'PROCEDURE', 'description': 'ultrasound measurement of caval aorta index', 'armGroupLabels': ['ultrasound-guided caval-aorta index group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'fixed fluid prescription', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maha Ahmed Abozeid, Assistant Professor', 'role': 'CONTACT', 'email': 'mahazed@yahoo.com', 'phone': '02-01019216192'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Surgical Intensive Care', 'investigatorFullName': 'maha abou-zeid', 'investigatorAffiliation': 'Mansoura University'}}}}