Clinical Trial: Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Safety and Efficacy of Conivaptan for the Correction of Euvolemic and Hypervolemic Hyponatremia in Critically Ill Neurological Patients

Brief Summary:

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.

Detailed Summary:
Sponsor: Columbia University

Current Primary Outcome: Mean change in serum sodium over the duration of treatment between the two treatment arms. [ Time Frame: From beginning of treatment to return of sodium level to greater than or equal to 135 mEq/L, up to 4 days of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction [ Time Frame: From the initiation of treatment to the end of treatment, up to 4 days ]

Original Secondary Outcome: The percentage of patients requiring study drug discontinuation for any reason other than reaching the sodium endpoint, including those with too rapid a rise in serum sodium (>12 mEq rise over 24 hours) or an infusion site reaction [ Time Frame: From the initiation of treatment to the end of treatment, up to 4 days ]

Information By: Columbia University

Dates:
Date Received: May 22, 2008
Date Started: May 2008
Date Completion: June 2010
Last Updated: March 5, 2015
Last Verified: March 2015