An interventional study of Glutamine and Ringer's Lactate in Hemorrhagic Shock, sponsored by University of Missouri, Kansas City. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-17.
Sponsored by University of Missouri, Kansas City · Not applicable, Interventional, and Treatment
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.
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.
78 studies on the registry are indexed under Shock, Hemorrhagic; 17 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 39 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →University of Missouri, Kansas City is the lead sponsor of 47 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ringer's Lactate 1 liter once over 6 hours
Drug: Ringer's Lactate · Drug: Placebo (for Glutamine)
Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
Drug: Glutamine · Drug: Ringer's Lactate
Intravenous 25 grams once over 6 hours
Intravenous 1 liter once over 6 hours
Also known as: Lactated Rigner's (LR)
Given Intravenously in 1 liter Lactated Ringer's
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
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.
| Milestone | Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | Glutamine: Intravenous 25 Grams Once Over 6 Hours |
|---|---|---|
| Started | 3 | 2 |
| Completed | 1 | 2 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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%. .
No measurements were reported for this outcome.
Collected over 4 years total.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | — | 0/3 (0%) | 0/3 (0%) |
| Glutamine: Intravenous 25 Grams Once Over 6 Hours | — | 0/2 (0%) | 0/2 (0%) |
| Age, Customized(participants) | Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | Glutamine: Intravenous 25 Grams Once Over 6 Hours | Total |
|---|---|---|---|
| Age 21-65 | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | Glutamine: Intravenous 25 Grams Once Over 6 Hours | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 3 | 2 | 5 |
| Region of Enrollment(participants) | Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours | Glutamine: Intravenous 25 Grams Once Over 6 Hours | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Missouri, Kansas City