Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
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).
Timeline
- Start
- 2008-08
- Primary completion
- 2010-01
- Completion
- 2010-02
Outcome
Met primary endpoint
Stopped (Enrollment): “Enrollment below goal.”
paper Conivaptan led to higher serum sodium compared to usual care. PMID 20568023 ↗
paper The change in serum sodium from baseline, the pre-specified endpoint, was significantly different between groups at six (7.0 +/- 1.7 vs. -0.6 +/- 2.1 mmol/l, P = 0.008) PMID 20568023 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Conivaptan | Small molecule | 20 mg | Intravenous |
Indications
No indication recorded.