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Hypertonic Modulation of Inflammation Following Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750997
Recruitment Status : Terminated (Enrollment in the clinical trial was stopped for futility)
First Posted : September 11, 2008
Last Update Posted : May 1, 2017
Information provided by (Responsible Party):
Eileen Bulger, University of Washington

Brief Summary:

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.

Condition or disease Intervention/treatment
Hemorrhagic Shock Traumatic Brain Injury Drug: hypertonic saline

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hypertonic Modulation of Inflammation Following Injury
Study Start Date : November 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Hypertonic saline
Hypertonic resuscitation
Drug: hypertonic saline
patients in parent trial were randomized to 250cc 7.5% saline, 7.5%saline with 6%dextran or normal saline as control as the initial resuscitation fluid after injury with signs of either hemorrhagic shock or severe traumatic brain injury
Other Name: hypertonic saline with dextran

Control: normal saline
Normal saline resuscitation

Primary Outcome Measures :
  1. neutrophil activation [ Time Frame: Emergency department admission ]
    several parameters of neutrophil activation were assessed

Secondary Outcome Measures :
  1. Endothelial cell activation [ Time Frame: Emergency department admission ]
    several parameters of endothelial cell activation were assessed

  2. coagulation parameters [ Time Frame: Emergency department admission ]
    several parameters of coagulation were assessed

  3. monocyte activation [ Time Frame: Emergency department admission ]
    several parameters of monocyte activation were assessed

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in clinical trial of Hypertonic Resuscitation based on prehospital evidence of hypovolemic shock or severe brain injury

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750997

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United States, Washington
University of Washington
Seattle, Washington, United States, 98104
University of Toronto
Toronto, Canada
Sponsors and Collaborators
University of Washington
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Principal Investigator: Eileen M Bulger, MD University of Washington
Publications of Results:
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Responsible Party: Eileen Bulger, Professor, Surgery, University of Washington Identifier: NCT00750997    
Other Study ID Numbers: 28233
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data from the primary RCT will be made available through the Resuscitation Outcomes consortium. This was an ancillary study
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Shock, Hemorrhagic
Wounds and Injuries
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Plasma Substitutes
Blood Substitutes