Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00930202
Status:
COMPLETED
Last Update Posted:
2010-09-10
First Post:
2009-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe 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': 'C106389', 'term': 'conivaptan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-08', 'studyFirstSubmitDate': '2009-06-26', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).', 'timeFrame': 'Every 4 hours'}], 'secondaryOutcomes': [{'measure': 'Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.', 'timeFrame': 'Hospital Stay'}, {'measure': 'Sodium load: Sodium load is defined as the cumulative amount of sodium administered by enteral and parenteral routes from the time of randomization to 48 hours post-randomization', 'timeFrame': 'Until 48 hours post randomization'}, {'measure': 'Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization', 'timeFrame': 'Until 48 hours post randomization'}, {'measure': 'Fluid balance', 'timeFrame': 'Until 48 hours post randomization'}, {'measure': 'Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema', 'timeFrame': 'Until 48 hours post randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'Conivaptan', 'Vaprisol', 'Sodium'], 'conditions': ['Severe Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or greater\n* Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of 8 or less upon initial evaluation)\n* Cerebral edema with a head CT and Marshall classification of diffuse injury type II, III, or IV.\n* Primary care team orders to raise blood sodium by 10 mEq/L from baseline.\n* Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure (ICP).\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Signs of hypovolemia including systolic BP \\< 90 mmHg\n* Signs of liver disease including jaundice and ascites\n\n * AST \\> 35 units/L\n * ALT \\> 35 units/L\n* Signs of renal disease including history of dialysis\n\n * Serum creatinine \\> 1.5 mg/dL\n * BUN \\> 20 mg/dL range\n* Baseline serum sodium \\>/= 145 mEq/L\n* Pregnant or lactating females\n* Concomitant use of digoxin, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, simvastatin and lovastatin\n* Presentation to the tertiary care hospital \\> 24 hours post-injury\n* Multi-system traumatic injuries\n* Diabetes Insipidus\n* Anticipation of diagnosis compatible with brain death, or no expectation of survival with 48 hours.'}, 'identificationModule': {'nctId': 'NCT00930202', 'briefTitle': 'Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '35774-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conivaptan (Vaprisol)', 'description': 'Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.', 'interventionNames': ['Drug: Conivaptan (Vaprisol)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'No intervention'}], 'interventions': [{'name': 'Conivaptan (Vaprisol)', 'type': 'DRUG', 'description': 'Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.', 'armGroupLabels': ['Conivaptan (Vaprisol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Miriam Treggiari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Miriam Treggiari, Associate Professor of Anesthesiology & Pain Medicine', 'oldOrganization': 'University of Washington'}}}}