Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhagic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ringer's Lactate and Placebo for Glutamine

Ringer's Lactate 1 liter once over 6 hours

Group Type PLACEBO_COMPARATOR

Ringer's Lactate

Intervention Type DRUG

Intravenous 1 liter once over 6 hours

Placebo (for Glutamine)

Intervention Type DRUG

Given Intravenously in 1 liter Lactated Ringer's

Ringer's Lactate with 25 grams Glutamine

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

Group Type EXPERIMENTAL

Glutamine

Intervention Type DRUG

Intravenous 25 grams once over 6 hours

Ringer's Lactate

Intervention Type DRUG

Intravenous 1 liter once over 6 hours

Interventions

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Glutamine

Intravenous 25 grams once over 6 hours

Intervention Type DRUG

Ringer's Lactate

Intravenous 1 liter once over 6 hours

Intervention Type DRUG

Placebo (for Glutamine)

Given Intravenously in 1 liter Lactated Ringer's

Intervention Type DRUG

Other Intervention Names

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Lactated Rigner's (LR)

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No