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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.
Harborview Medical Center
Seattle, Washington, United States
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).
Time frame: Every 4 hours
Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.
Time frame: Hospital Stay
Sodium load: Sodium load is defined as the cumulative amount of sodium administered by enteral and parenteral routes from the time of randomization to 48 hours post-randomization
Time frame: Until 48 hours post randomization
Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization
Time frame: Until 48 hours post randomization
Fluid balance
Time frame: Until 48 hours post randomization
Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema
Time frame: Until 48 hours post randomization
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