Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
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).