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Completed

NCT Number: NCT00930202

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.

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Key information

Conditions

Severe Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conivaptan (Vaprisol)

Drug

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 outcomes

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

    Time frame: Every 4 hours

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Fluid balance

    Time frame: Until 48 hours post randomization

  5. Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema

    Time frame: Until 48 hours post randomization

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2009
Registry last updated
Sep 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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