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

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00930202
First received: June 26, 2009
Last updated: September 8, 2010
Last verified: September 2010

June 26, 2009
September 8, 2010
August 2009
May 2010   (final data collection date for primary outcome measure)
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr). [ Time Frame: Every 4 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00930202 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Fluid balance [ Time Frame: Until 48 hours post randomization ] [ Designated as safety issue: No ]
  • Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema [ Time Frame: Until 48 hours post randomization ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Traumatic Brain Injury
Drug: Conivaptan (Vaprisol)
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.
Other Name: Conivaptan (Vaprisol)
  • Experimental: Conivaptan (Vaprisol)
    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.
    Intervention: Drug: Conivaptan (Vaprisol)
  • No Intervention: Standard Care
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00930202
35774-A
Yes
Miriam Treggiari, Associate Professor of Anesthesiology & Pain Medicine, University of Washington
University of Washington
Not Provided
Principal Investigator: Miriam Treggiari, MD University of Washington
University of Washington
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP