Hyponatremia Clinical Trial
Official title:
Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients
Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in
particular those with neurological injury. Hyponatremia has been associated with worse
outcome, problems with memory and concentration and impaired balance. Standard treatment for
low sodium (salt) levels is to give the patient a salt containing solution thru a catheter
(small flexible tube) in a vein in the arm or leg. One of the major complications of this
treatment is excess body fluid which may cause heart problems or accumulation of fluid in
the lungs and may require additional medications to remove extra water from the body.
FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic
conditions. Conivaptan works by excreting free water from the body and thereby produce
concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated
specifically in patients with brain injuries. The primary objective of this study is to
demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of
hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe
treatment option.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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