Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
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Purpose
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 | Intervention |
|---|---|
|
Hemorrhagic Shock |
Drug: Glutamine Drug: Ringer's Lactate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy. |
- Biological response as characterized by microarray analysis, selected cytokines, TNFα, IL-1, IL-6 [ Time Frame: Change from Baseline in Inflammatory Gene Activation at 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Standard Fluid Resuscitation
Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate
|
Drug: Glutamine
Intravenous 25 grams once over 6 hours
Drug: Ringer's Lactate
Intravenous 1 liter once over 6 hours
|
|
Experimental: Standard fluid resuscitation
Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine
|
Drug: Glutamine
Intravenous 25 grams once over 6 hours
Drug: Ringer's Lactate
Intravenous 1 liter once over 6 hours
|
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| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Blunt or penetrating trauma patients who meet TMC 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| Contact: Kim Dyer, RN, MS, CCRC | 816-404-1380 | kim.dyer@tmcmed.org |
| United States, Missouri | |
| Truman Medical Center-Hospital Hill | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Mickie Keeling, RN, CCRC 816-404-1381 mickie.keeling@tmcmed.org | |
| Sub-Investigator: Douglas Geehan, MD | |
| Principal Investigator: Charles Van Way, III, MD | |
| Univeristy of Missouri-Kansas City | Not yet recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Charles Van Way, M.D. 816-235-2553 vanwayc@umkc.edu | |
| Contact: Kathy A Vernon 816-235-1917 vernonka@umkc.edu | |
| Principal Investigator: Charles Van Way, M.D. | |
| Sub-Investigator: Nilofer Qureshi, Ph.D. | |
| Principal Investigator: | Charles Van Way, III, M.D. | University of Missouri, Kansas City |
More Information
No publications provided
| Responsible Party: | University of Missouri, Kansas City |
| ClinicalTrials.gov Identifier: | NCT01239680 History of Changes |
| Other Study ID Numbers: | 05-18 |
| Study First Received: | October 12, 2010 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Missouri, Kansas City:
|
hemorrhagic shock glutamine trauma resuscitation department of defense trauma |
Additional relevant MeSH terms:
|
Shock Shock, Hemorrhagic Wounds and Injuries Pathologic Processes Hemorrhage |
ClinicalTrials.gov processed this record on May 23, 2013