drugset / Trial / NCT00930202

Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury

NCT00930202

Phase 1 Completed 10 enrolled University of Washington
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.

Timeline

Start
2009-08
Primary completion
2010-05
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Conivaptan Small molecule 20 mg