Clinical trial NCT01239680: Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Official title: Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhagic Shock
Keywords: hemorrhagic shock
glutamine
trauma resuscitation
department of defense
trauma
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2010-11-11
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).
timeFrame: Change from Baseline in Cytokine Levels at 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center-Hospital Hill
state: Missouri
city: Kansas City
country: United States
facility: Univeristy of Missouri-Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Charles Van Way, III, M.D.
role: PRINCIPAL_INVESTIGATOR
References: