Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00113685 |
Other study ID # |
20737 |
Secondary ID |
R01HL073233 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2003 |
Est. completion date |
March 2007 |
Study information
Verified date |
April 2021 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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:
This randomized clinical trial seeks to evaluate the clinical outcome and inflammatory cell
function of patients in shock following blunt traumatic injury who are randomized to receive
either 7.5% hypertonic saline/6% dextran (HSD) followed by lactated ringer's solution or
lactated ringer's solution alone. It is hypothesized that HSD resuscitation will inhibit the
initial excessive systemic activation of the inflammatory response, which will translate into
a reduction in the incidence of organ dysfunction typically induced by this response.
Furthermore, the study will evaluate the impact of HSD resuscitation on recovery following
traumatic brain injury, as previous studies suggest that this subgroup has the greatest
survival advantage from HSD intervention. The specific aims for this study include the
following: Aim 1: To determine the impact of pre-hospital administration of HSD on the
development of organ failure following blunt traumatic injury with hypovolemic shock. Aim 2:
To determine the impact of pre-hospital administration of HSD on the neurologic outcome
following brain injury for patients in hypovolemic shock. Aim 3a: To determine the effect of
pre-hospital administration of HSD on the activation of circulating neutrophils and
monocytes. Aim 3b: To determine the effect of pre-hospital administration of HSD on the
activation of T lymphocytes. The study builds upon previous research that has demonstrated
the safety and practicality of this resuscitation strategy in the pre-hospital environment. A
more detailed understanding of the immuno-inflammatory effects of hypertonicity for all
patients and the long-term neurologic outcome for patients with brain injury is critical for
determining the role of this resuscitation approach in such critically injured patients.