Status:
COMPLETED
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
Lead Sponsor:
University of Washington
Conditions:
Severe Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00930202
Start Date
August 1 2009
End Date
June 1 2010
Last Update
September 10 2010
Active Locations (1)
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1
Harborview Medical Center
Seattle, Washington, United States, 98104