Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT01239680
First received: October 12, 2010
Last updated: May 14, 2014
Last verified: May 2014

October 12, 2010
May 14, 2014
January 2011
November 2013   (final data collection date for primary outcome measure)
Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6). [ Time Frame: Change from Baseline in Cytokine Levels at 24 hours ] [ Designated as safety issue: No ]
Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .
Biological response as characterized by microarray analysis, selected cytokines, TNFα, IL-1, IL-6 [ Time Frame: Cytokines at 24 hours and at 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01239680 on ClinicalTrials.gov Archive Site
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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.

Overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield, in civilian life, or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought.

Shock is a leading cause of death among American forces in battle, with many trauma victims dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the body's vital organs and tissues. Specifically, hemorrhagic shock results when blood vessels are physically damaged while septic shock results when microbes or microbial products enter the blood stream. Despite advances in medical science, including the development of improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the United States, is treated today largely as he or she would have been treated in 1970.

The overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield (medical corpsmen, combat medics), in civilian life (Emergency Medical System), or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. This might be a Fire Support Specialist (FIST) team in a combat theater or a trauma center in the civilian health care system.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hemorrhagic Shock
  • Drug: Glutamine
    Intravenous 25 grams once over 6 hours
    Other Name: Glutamine
  • Drug: Ringer's Lactate
    Intravenous 1 liter once over 6 hours
    Other Names:
    • Ringer's Lactate
    • Lactated Rigner's (LR)
  • Drug: Placebo (for Glutamine)
    Given Intravenously in 1 liter Lactated Ringer's
  • Placebo Comparator: Ringer's Lactate and Placebo for Glutamine
    Ringer's Lactate 1 liter once over 6 hours
    Interventions:
    • Drug: Ringer's Lactate
    • Drug: Placebo (for Glutamine)
  • Experimental: Ringer's Lactate with 25 grams Glutamine
    Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
    Interventions:
    • Drug: Glutamine
    • Drug: Ringer's Lactate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Blunt or penetrating trauma patients who meet Truman Medical Center criteria for a trauma activation.
  • These patients will typically be in shock and have blunt injuries or penetrating trauma.
  • Patients must be alert, awake, oriented, and responsive and be English speaking males or females between the ages 21-65.

Exclusion Criteria:

  • traumatic cardiac arrest patients,
  • pregnant patients,
  • interhospital transfer patients,
  • non-English speaking patients,
  • patients with suspected or confirmed Human Immunodeficiency Virus (HIV) or AIDs based on clear history,
  • prior laboratory tests, or strong clinical suspicion; patients with clinical evidence of impaired mental function;
  • patients with continuing hypotension or tachycardia after resuscitation;
  • patients with blood alcohol in excess of 80mg/dl;
  • signs suggestive of coagulopathy;
  • allergy to glutamine;
  • liver disease or renal disease.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01239680
05-18
No
University of Missouri, Kansas City
University of Missouri, Kansas City
Department of Defense
Principal Investigator: Charles Van Way, III, M.D. University of Missouri, Kansas City
University of Missouri, Kansas City
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP