Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
Completed · Phase 1
Conditions studied: Severe Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00930202
- Run by
- University of Washington
- People needed
- 10
- Starts
- 2009-08-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2010-09-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Harborview Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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