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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930202
First Posted: June 30, 2009
Last Update Posted: September 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Washington
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]
  • 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 ]
  • 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 ]
  • Fluid balance [ Time Frame: Until 48 hours post randomization ]
  • Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema [ Time Frame: Until 48 hours post randomization ]

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.
No Intervention: Standard Care
No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 26, 2009
First Posted: June 30, 2009
Last Update Posted: September 10, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Conivaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs