Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Study Overview
=================
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.

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.

Official Title
-----------------
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.

Conditions
-----------------
Hemorrhagic Shock

Intervention / Treatment
-----------------
* Drug: Glutamine
* Drug: Ringer's Lactate
* Drug: Placebo (for Glutamine)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ringer's Lactate and Placebo for Glutamine<br>Ringer's Lactate 1 liter once over 6 hours | Drug: Ringer's Lactate<br>* Intravenous 1 liter once over 6 hours<br>* Other names: Lactated Rigner's (LR);Drug: Placebo (for Glutamine)<br>* Given Intravenously in 1 liter Lactated Ringer's<br>|
| Experimental: Ringer's Lactate with 25 grams Glutamine<br>Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours | Drug: Glutamine<br>* Intravenous 25 grams once over 6 hours<br>Drug: Ringer's Lactate<br>* Intravenous 1 liter once over 6 hours<br>* Other names: Lactated Rigner's (LR);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6). | 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%. . | Change from Baseline in Cytokine Levels at 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma