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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

Page last updated: August 23, 2015

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