Traumatic Brain Injury Clinical Trial
Official title:
Hypertonic Modulation of Inflammation Following Injury
Verified date | April 2017 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 119 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Blunt or Penetrating trauma with prehospital systolic blood pressure < 70 or 70-90 mmHg with Heart rate > 108 OR Blunt trauma with prehospital Glasgow coma score <= 8 Exclusion Criteria: - Age < 15 yrs - Known prisoners - Pregnancy - Ongoing Cardiopulmonary resuscitation (CPR) - Burns < 20% - Hypothermia < 28 C - > 2 liters intravenous fluid prior to study fluid administration - > 4 hour from time of dispatch |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Toronto | |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States, Canada,
Bulger EM, Tower CM, Warner KJ, Garland T, Cuschieri J, Rizoli S, Rhind S, Junger WG. Increased neutrophil adenosine a3 receptor expression is associated with hemorrhagic shock and injury severity in trauma patients. Shock. 2011 Nov;36(5):435-9. doi: 10.1 — View Citation
Delano MJ, Rizoli SB, Rhind SG, Cuschieri J, Junger W, Baker AJ, Dubick MA, Hoyt DB, Bulger EM. Prehospital Resuscitation of Traumatic Hemorrhagic Shock with Hypertonic Solutions Worsens Hypocoagulation and Hyperfibrinolysis. Shock. 2015 Jul;44(1):25-31. — View Citation
Junger WG, Rhind SG, Rizoli SB, Cuschieri J, Baker AJ, Shek PN, Hoyt DB, Bulger EM. Prehospital hypertonic saline resuscitation attenuates the activation and promotes apoptosis of neutrophils in patients with severe traumatic brain injury. Shock. 2013 Nov — View Citation
Junger WG, Rhind SG, Rizoli SB, Cuschieri J, Shiu MY, Baker AJ, Li L, Shek PN, Hoyt DB, Bulger EM. Resuscitation of traumatic hemorrhagic shock patients with hypertonic saline-without dextran-inhibits neutrophil and endothelial cell activation. Shock. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | neutrophil activation | several parameters of neutrophil activation were assessed | Emergency department admission | |
Secondary | Endothelial cell activation | several parameters of endothelial cell activation were assessed | Emergency department admission | |
Secondary | coagulation parameters | several parameters of coagulation were assessed | Emergency department admission | |
Secondary | monocyte activation | several parameters of monocyte activation were assessed | Emergency department admission |
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