Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Status Terminated

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hyponatremia

Clinical Trial Details

NCT number	NCT00727090
Study type	Interventional
Source	Northwestern University
Contact
Status	Terminated
Phase	Phase 4
Start date	August 2008
Completion date	February 2010

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