Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-25 @ 12:43 AM
Study NCT ID:
NCT03828032
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2019-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D001929', 'term': 'Brain Edema'}, {'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008353', 'term': 'Mannitol'}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Δ[HbO2]', 'timeFrame': '2 weeks', 'description': 'changes of oxyhemoglobin concentration'}, {'measure': 'water concentration', 'timeFrame': '2 weeks', 'description': 'water concentration of brain'}], 'secondaryOutcomes': [{'measure': 'intracranial pressure', 'timeFrame': '2 weeks', 'description': 'intracranial pressure'}, {'measure': 'Δ[Hb]', 'timeFrame': '2 weeks', 'description': 'changes of deoxy-hemoglobin concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain edema', 'dehydration', 'Noninvasive optical method'], 'conditions': ['Hemodynamic Instability', 'Water on the Brain', 'Intracranial Pressure Increase']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\\[HbO2\\]), deoxy-hemoglobin (\\[Hb\\]), the derived change in blood volume (\\[tHb\\]) and water concentration on the forehead of brain edema patients.', 'detailedDescription': 'Cerebral edema, as an acute head injury along with high intracranial pressure, has been of great interest over decades in clinical neurosurgery research. Dehydration therapy is a common clinical method to decrease intracranial pressure. This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\\[HbO2\\]), deoxy-hemoglobin (\\[Hb\\]), the derived change in blood volume (\\[tHb\\]) and water concentration on the forehead of brain edema patients. Then the investigators compared the changes process of multiple physiological parameters during different dehydration therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.\n\nExclusion Criteria:\n\n* AIDS, Active Hepatitis, Tuberculosis, Syphilis\n* Patients who regularly take anticoagulants, antiplatelet drugs\n* Anemia, thrombocytopenia\n* Hemorrhagic disease like hemophilia'}, 'identificationModule': {'nctId': 'NCT03828032', 'briefTitle': "Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.", 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients', 'orgStudyIdInfo': {'id': 'Brain edema dehydration'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mannitol injection', 'description': 'The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.', 'interventionNames': ['Procedure: Mannitol injection']}, {'type': 'EXPERIMENTAL', 'label': 'Hypertonic saline injection', 'description': 'The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.', 'interventionNames': ['Procedure: Hypertonic saline injection']}], 'interventions': [{'name': 'Mannitol injection', 'type': 'PROCEDURE', 'description': 'Standard mannitol injection to decrease intracranial pressure of patients', 'armGroupLabels': ['Mannitol injection']}, {'name': 'Hypertonic saline injection', 'type': 'PROCEDURE', 'description': 'Standard Hypertonic saline injection to decrease intracranial pressure of patients', 'armGroupLabels': ['Hypertonic saline injection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ting Li', 'class': 'UNKNOWN'}, 'collaborators': [{'name': 'Affiliated Hospital of Armed Police Logistics College', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Ting Li', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}