Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

University of Missouri, Kansas City

Status: Completed

Conditions: Hemorrhagic Shock

Treatments: Drug: Placebo (for Glutamine); Drug: Ringer's Lactate; Drug: Glutamine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01239680

05-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Ringer's Lactate and Placebo for Glutamine

Placebo Comparator group

Description:

Ringer's Lactate 1 liter once over 6 hours

Treatment:

Drug: Placebo (for Glutamine)

Drug: Ringer's Lactate

Ringer's Lactate with 25 grams Glutamine

Experimental group

Description:

Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours

Treatment:

Drug: Ringer's Lactate

Drug: Glutamine