Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT03330704
Status:
WITHDRAWN
Last Update Posted:
2020-03-19
First Post:
2017-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001929', 'term': 'Brain Edema'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of eligible study participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume of intravenous hypertonic fluid administered to the patient', 'timeFrame': 'The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment', 'description': 'Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.'}], 'secondaryOutcomes': [{'measure': 'Urine output', 'timeFrame': 'Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment', 'description': 'Urine output will be collected and measured quantitatively in milliliter units.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Edema', 'Saline Solution, Hypertonic']}, 'referencesModule': {'references': [{'pmid': '6826732', 'type': 'BACKGROUND', 'citation': 'Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. doi: 10.1172/jci110820.'}, {'pmid': '18090381', 'type': 'BACKGROUND', 'citation': 'Toung TJ, Nyquist P, Mirski MA. Effect of hypertonic saline concentration on cerebral and visceral organ water in an uninjured rodent model. Crit Care Med. 2008 Jan;36(1):256-61. doi: 10.1097/01.CCM.0000295306.52783.1E.'}, {'pmid': '16174920', 'type': 'BACKGROUND', 'citation': 'Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. doi: 10.1385/NCC:1:2:219.'}, {'pmid': '28042364', 'type': 'BACKGROUND', 'citation': 'Erdman MJ, Riha H, Bode L, Chang JJ, Jones GM. Predictors of Acute Kidney Injury in Neurocritical Care Patients Receiving Continuous Hypertonic Saline. Neurohospitalist. 2017 Jan;7(1):9-14. doi: 10.1177/1941874416665744. Epub 2016 Aug 29.'}, {'pmid': '23636658', 'type': 'BACKGROUND', 'citation': 'Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium acetate as a replacement for sodium bicarbonate in medical toxicology: a review. J Med Toxicol. 2013 Sep;9(3):250-4. doi: 10.1007/s13181-013-0304-0.'}]}, 'descriptionModule': {'briefSummary': 'Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to consent\n* 18 years or older\n* English speaking\n* Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration\n\nExclusion Criteria:\n\n* Fails to consent\n* \\< 18 years old\n* Hypertonic therapy not indicated'}, 'identificationModule': {'nctId': 'NCT03330704', 'briefTitle': 'Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema', 'orgStudyIdInfo': {'id': 'IRB-43653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': 'This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation.', 'interventionNames': ['Drug: 3% Sodium Chloride']}, {'type': 'EXPERIMENTAL', 'label': 'Balanced Therapy', 'description': 'This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach', 'interventionNames': ['Drug: 23.4% Sodium Chloride', 'Drug: 8.4% Sodium Bicarbonate']}], 'interventions': [{'name': '3% Sodium Chloride', 'type': 'DRUG', 'description': '3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure', 'armGroupLabels': ['Standard Therapy']}, {'name': '23.4% Sodium Chloride', 'type': 'DRUG', 'description': '23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure', 'armGroupLabels': ['Balanced Therapy']}, {'name': '8.4% Sodium Bicarbonate', 'type': 'DRUG', 'description': '8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure', 'armGroupLabels': ['Balanced Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Tim Angelotti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Tim Angelotti', 'investigatorAffiliation': 'Stanford University'}}}}