Traumatic Brain Injury Clinical Trial
Official title:
Hypertonic Modulation of Inflammation Following Injury
This project seeks to determine the effect of prehospital resuscitation with hypertonic
saline vs. conventional crystalloids on the inflammatory response after injury. The leading
cause of late mortality following injury is multiple organ dysfunction syndrome (MODS),
which results from a dysfunctional inflammatory response after injury. Previous studies
suggest that hypertonic saline may be beneficial by modulating this initial response and
decreasing subsequent organ injury. This project takes advantage of a unique opportunity,
afforded by an NIH-funded multi-center clinical trial of hypertonic resuscitation (conducted
by the Resuscitation Outcomes Consortium), to obtain blood samples from patients enrolled in
this trial to analyze inflammatory responses early after hypertonic vs. conventional
resuscitation. This study was an ancillary study to the main randomized clinical trial and
thus prospective observational in nature
The proposed study will be carried out in experiments grouped in three Specific Aims: Aim 1
provides a thorough investigation of the immunomodulatory response following hypertonic
resuscitation with regard to neutrophil, monocyte, and T cell responses at serial time
points after injury and resuscitation. Aim 2 comprises experiments to investigate the
mechanisms by which hypertonicity may alter inflammatory cell signaling. Aim 3 seeks to
correlate the laboratory findings with clinical endpoints reflective of immune dysfunction
including inflammation, organ failure, nosocomial infection, and sepsis.
The investigators hypothesize that hypertonic resuscitation will be associated with
modulation of the excessive inflammatory response seen after injury and thus will result in
reduced rates of inflammatory organ injury.
This was an ancillary study to the larger clinical trials of prehospital hypertonic resuscitation conducted by the resuscitation outcomes consortium. This study investigated markers of immune function and coagulation in a subset of patients enrolled in the larger trials at two of the clinical sites. Four publications detail the results please see references ;
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