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Sponsored by: |
National Institute of General Medical Sciences (NIGMS) |
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Information provided by: | National Institute of General Medical Sciences (NIGMS) |
ClinicalTrials.gov Identifier: | NCT00750997 |
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.
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 |
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Hemorrhagic Shock Traumatic Brain Injury |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Hypertonic Modulation of Inflammation Following Injury |
plasma
Estimated Enrollment: | 300 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2010 |
Groups/Cohorts |
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I
Hypertonic resuscitation
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2
Normal saline resuscitation
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Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients enrolled in clinical trial of Hypertonic Resuscitation based on prehospital evidence of hypovolemic shock or severe brain injury
Inclusion Criteria:
Exclusion Criteria:
Contact: Eileen Bulger, MD | 206-744-6448 | ebulger@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98104 | |
Principal Investigator: Eileen Bulger, MD | |
Canada | |
University of Toronto | Recruiting |
Toronto, Canada | |
Principal Investigator: Sandro Rizoliq, MD |
Principal Investigator: | Eileen M Bulger, MD | University of Washington |
Responsible Party: | University of Washington ( Eileen M. Bulger, MD ) |
Study ID Numbers: | R01 GM076101-02 |
Study First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00750997 |
Health Authority: | United States: Food and Drug Administration |
Craniocerebral Trauma Shock Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Brain Diseases Hemorrhage Brain Injuries Shock, Hemorrhagic Inflammation |
Pathologic Processes Nervous System Diseases |