- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239680
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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Kansas City, Missouri, United States, 64108
- Univeristy of Missouri-Kansas City
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Kansas City, Missouri, United States, 64108
- Truman Medical Center-Hospital Hill
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Ringer's Lactate and Placebo for Glutamine
Ringer's Lactate 1 liter once over 6 hours
|
Intravenous 1 liter once over 6 hours
Other Names:
Given Intravenously in 1 liter Lactated Ringer's
|
EXPERIMENTAL: Ringer's Lactate with 25 grams Glutamine
Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
|
Intravenous 1 liter once over 6 hours
Other Names:
Intravenous 25 grams once over 6 hours
|
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).
Time Frame: Change from Baseline in Cytokine Levels at 24 hours
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charles Van Way, III, M.D., University of Missouri, Kansas City
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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