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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

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ClinicalTrials.gov Identifier: NCT01239680
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Missouri, Kansas City

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Shock Drug: Glutamine Drug: Ringer's Lactate Drug: Placebo (for Glutamine) Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
Study Start Date : January 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Ringer's Lactate and Placebo for Glutamine
Ringer's Lactate 1 liter once over 6 hours
 Drug: Ringer's Lactate
Intravenous 1 liter once over 6 hours
Other Name: Lactated Rigner's (LR)

Drug: Placebo (for Glutamine)
Given Intravenously in 1 liter Lactated Ringer's
Experimental: Ringer's Lactate with 25 grams Glutamine
Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
 Drug: Glutamine
Intravenous 25 grams once over 6 hours

Drug: Ringer's Lactate
Intravenous 1 liter once over 6 hours
Other Name: Lactated Rigner's (LR)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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%. .


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01239680


Locations
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United States, Missouri
Truman Medical Center-Hospital Hill
Kansas City, Missouri, United States, 64108
Univeristy of Missouri-Kansas City
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Missouri, Kansas City
United States Department of Defense
Investigators
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Principal Investigator: Charles Van Way, III, M.D. University of Missouri, Kansas City
More Information
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Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01239680    
Other Study ID Numbers: 05-18
First Posted: November 11, 2010    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014
Keywords provided by University of Missouri, Kansas City:
hemorrhagic shock
glutamine
trauma resuscitation
department of defense
trauma
Additional relevant MeSH terms:
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Shock, Hemorrhagic
Wounds and Injuries
Shock
Pathologic Processes
Hemorrhage