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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours
Change in Serum Sodium From Baseline to 6 Hours
Time frame: 48 hours
NIH Stroke Scale
Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).
Time frame: 48 hours
Glasgow Coma Scale
Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)
Time frame: 48 hours
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