Hypertonic Modulation of Inflammation Following Injury

This study has been terminated.
(Enrollment in the clinical trial was stopped for futility)
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00750997
First received: September 10, 2008
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

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
Hemorrhagic Shock
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hypertonic Modulation of Inflammation Following Injury

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 119
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
I
Hypertonic resuscitation
2
Normal saline resuscitation

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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

Criteria

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 CPR
  • Burns < 20%
  • Hypothermia < 28 C
  • > 2 liters intravenous fluid prior to study fluid administration
  • > 4 hour from time of dispatch
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750997

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Canada
University of Toronto
Toronto, Canada
Sponsors and Collaborators
Investigators
Principal Investigator: Eileen M Bulger, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Eileen M. Bulger, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00750997     History of Changes
Other Study ID Numbers: R01 GM076101-02
Study First Received: September 10, 2008
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Shock
Shock, Hemorrhagic
Brain Injuries
Wounds and Injuries
Pathologic Processes
Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014