Clinical Trial: Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Hypertonic Resuscitation for Blunt Trauma

Brief Summary: The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.

Detailed Summary:

BACKGROUND:

Trauma is the leading cause of death among Americans between the ages of 1 and 35 years. The majority of these deaths result from hypovolemic shock, a type of shock in which the heart is unable to supply enough blood to the body, and the resulting severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia with a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation of these patients involves the intravenous administration of a large volume of isotonic or slightly hypotonic (lactated ringers) solutions beginning in the pre-hospital environment. Previous studies have suggested that an alternative resuscitation fluid, HSD, may reduce mortality in these patients; but these studies have not been conclusive. Furthermore, HSD may have specific advantages in the brain-injured patient, as it may aid in the rapid restoration of cerebral perfusion, prevent extravascular fluid sequestration, and thus, limit secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, which may result in a reduction in subsequent organ injury following whole body ischemia/reperfusion and ultimately decrease nosocomial infection rates.

Blunt trauma victims with low blood pressures will be identified by pre-hospital providers (paramedics and flight nurses) and randomized to receive either 250 cc of HSD or 250 cc of isotonic solution (lactated ringer's solution). Lactated ringer's solution is the current standard of care with which the ambulances and helicopters will be supplied. All bags of study solution will be prepared by the Harborview Medical Center pharmacy.

DESIGN NARRATIVE:

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Sponsor: University of Washington

Current Primary Outcome: Adult respiratory distress syndrome symptoms (measured 28 days post-injury)

Original Primary Outcome:

Current Secondary Outcome:

  • Multiple organ failure syndrome
  • 28 day mortality
  • Nosocomial infections
  • Duration of hospital and ICU stay
  • Duration of mechanical ventilation
  • Neurologic outcome for patients with traumatic brain injury based on the Glasgow Outcome Score and Disability Rating Score (measured at 6 and 12 months post-injury)


Original Secondary Outcome:

Information By: University of Washington

Dates:
Date Received: June 9, 2005
Date Started: April 2003
Date Completion: March 2007
Last Updated: February 8, 2016
Last Verified: April 2007