Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Severe Traumatic Brain Injury
 Drug: Conivaptan (Vaprisol)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Number of events of excessive rate of increase in sodium levels (>1 mEq/hr). [ Time Frame: Every 4 hours ] [ Designated as safety issue: Yes ]

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. [ 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 ]

Estimated Enrollment: 10
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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)
No Intervention: Standard Care
No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930202

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Miriam Treggiari, MD University of Washington
  More Information

No publications provided

Responsible Party: Miriam Treggiari, Associate Professor of Anesthesiology & Pain Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00930202     History of Changes
Other Study ID Numbers: 35774-A
Study First Received: June 26, 2009
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Traumatic Brain Injury
Conivaptan
Vaprisol
Sodium

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013