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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: Conivaptan

Criteria

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 (ICP).

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.