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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 1
Accepts Healthy Volunteers?
Lead Sponsor:
University of Washington
Inclusion Criteria:

- 18 years old or greater

- Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of
8 or less upon initial evaluation)

- Cerebral edema with a head CT and Marshall classification of diffuse injury type II,
III, or IV.

- Primary care team orders to raise blood sodium by 10 mEq/L from baseline.

- Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure

Exclusion Criteria:

- Age < 18 years

- Signs of hypovolemia including systolic BP < 90 mmHg

- Signs of liver disease including jaundice and ascites

- AST > 35 units/L

- ALT > 35 units/L

- Signs of renal disease including history of dialysis

- Serum creatinine > 1.5 mg/dL

- BUN > 20 mg/dL range

- Baseline serum sodium >/= 145 mEq/L

- Pregnant or lactating females

- Concomitant use of digoxin, ketoconazole, itraconazole, clarithromycin, ritonavir,
indinavir, simvastatin and lovastatin

- Presentation to the tertiary care hospital > 24 hours post-injury

- Multi-system traumatic injuries

- Diabetes Insipidus

- Anticipation of diagnosis compatible with brain death, or no expectation of survival
with 48 hours.