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Enrollment below goal.
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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).
This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Conivaptan in addition to usual care at the discretion of the attending medical staff |
|
| 2 | No Intervention | Usual care by the attending physician staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conivaptan | Drug | Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Sodium From Baseline to 6 Hours | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Stroke Scale | Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible). | 48 hours |
| Glasgow Coma Scale | Standardized examination of mental status ranging from 3 (worst) to 15 (best possible) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Sodium From Baseline to 12 Hours | 12 hours | |
| Change in Serum Sodium From Baseline to 18 Hours | 18 hours | |
| Change in Serum Sodium From Baseline to 24 Hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Naidech, MD, MSPH | Northwestern University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20568023 | Derived | Naidech AM, Paparello J, Liebling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61. doi: 10.1007/s12028-010-9379-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment: Conivaptan | Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours |
| FG001 | Usual Medical Care | Usual care by the attending physician staff |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment: Conivaptan | Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours |
| BG001 | Usual Medical Care | Usual care by the attending physician staff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Sodium From Baseline to 6 Hours | Intention to treat | Posted | Mean | Standard Deviation | mMol/L | 48 hours |
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48 hours after study start
Hypovolemia, clincial diagnosis by intensivist or central venous pressure < 5 mmg Hg; Hypotension, systolic BP < 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment: Conivaptan | Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew M Naidech | Northwestern University | 312-503-3592 | a-naidech@northwestern.edu |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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| 48 hours |
| 24 hours |
| Change in Serum Sodium From Baseline to 36 Hours | 36 hours |
| Change in Serum Sodium From Baseline to 48 Hours | 48 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | NIH Stroke Scale | Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible). | Comparison of distribution; n enrolled was insufficient and trial was halted for poor recruitment. | Posted | Median | Full Range | score on a scale | 48 hours |
|
|
|
| Secondary | Glasgow Coma Scale | Standardized examination of mental status ranging from 3 (worst) to 15 (best possible) | all enrolled patients | Posted | Median | Full Range | score on a scale | 48 hours |
|
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| Other Pre-specified | Change in Serum Sodium From Baseline to 12 Hours | Posted | Mean | Standard Deviation | mMol/L | 12 hours |
|
|
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| Other Pre-specified | Change in Serum Sodium From Baseline to 18 Hours | Posted | Mean | Standard Deviation | mMol/L | 18 hours |
|
|
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| Other Pre-specified | Change in Serum Sodium From Baseline to 24 Hours | Posted | Mean | Standard Deviation | mMol/L | 24 hours |
|
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| Other Pre-specified | Change in Serum Sodium From Baseline to 36 Hours | Posted | Mean | Standard Deviation | mMol/L | 36 hours |
|
|
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| Other Pre-specified | Change in Serum Sodium From Baseline to 48 Hours | Posted | Mean | Standard Deviation | mMol/L | 48 hours |
|
|
|
| 2 |
| 3 |
| 0 |
| 3 |
| EG001 | Usual Medical Care | Usual care by the attending physician staff | 2 | 3 | 0 | 3 |
| Hypovolemia | Cardiac disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment | New core temperature at least 100.4F |
|
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