Study of the Safety and Efficacy of Conivaptan (Vaprisol�) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Traumatic Brain Injury
Intervention: Conivaptan (Vaprisol) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Miriam Treggiari, MD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).
Secondary outcome: Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.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 Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization Fluid balance Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Harborview Medical Center, Seattle, Washington 98104, United States
Additional Information
Starting date: August 2009
Last updated: September 8, 2010
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