Hemorrhagic Shock
Conditions
Keywords
hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma
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.
Interventions
DRUGGlutamine
Intravenous 25 grams once over 6 hours
DRUGRinger's Lactate
Intravenous 1 liter once over 6 hours
DRUGPlacebo (for Glutamine)
Given Intravenously in 1 liter Lactated Ringer's
Sponsors
United States Department of Defense
University of Missouri, Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6). | 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%. . |
Countries
United States
Participant flow
Recruitment details
Recruitment period started 01/12/2011. Recruitment ended 11/01/2013. Subjects were recruited from the Emergency Department and Intensive Care Units at Truman Medical Center Hospital Hill. These subjects were Trauma Activations. Recruitment was performed by the Principal Investigator, Research Coordinator, or other approved study staff.
Participants by arm
| Arm | Count |
|---|---|
| Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours | 3 |
| Glutamine: Intravenous 25 Grams Once Over 6 Hours Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | Glutamine: Intravenous 25 Grams Once Over 6 Hours | Total |
|---|---|---|---|
| Age, Customized Age 21-65 | 3 participants | 2 participants | 5 participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).
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%. .
Time frame: Change from Baseline in Cytokine Levels at 24 hours
Population: The number of participants who had an intervention and completed the study with all 3 required blood draws.