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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

Primary Purpose

Severe Traumatic Brain Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Conivaptan (Vaprisol)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Conivaptan, Vaprisol, Sodium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Conivaptan (Vaprisol)

Standard Care

Arm Description

Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.

No intervention

Outcomes

Primary Outcome Measures

Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2009
Last Updated
September 8, 2010
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00930202
Brief Title
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Conivaptan, Vaprisol, Sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conivaptan (Vaprisol)
Arm Type
Experimental
Arm Description
Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Conivaptan (Vaprisol)
Intervention Description
Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.
Primary Outcome Measure Information:
Title
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).
Time Frame
Every 4 hours
Secondary Outcome Measure Information:
Title
Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.
Time Frame
Hospital Stay
Title
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
Time Frame
Until 48 hours post randomization
Title
Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization
Time Frame
Until 48 hours post randomization
Title
Fluid balance
Time Frame
Until 48 hours post randomization
Title
Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema
Time Frame
Until 48 hours post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Treggiari, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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