Hemorrhagic ShockNCT01239680
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
A study testing Glutamine and Ringer's Lactate in people with Hemorrhagic Shock, run by University of Missouri, Kansas City at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Hemorrhagic Shock
- What is being tested?
- Glutamine and Ringer's Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Truman Medical Center-Hospital Hill
Kansas City, Missouri, 64108
Univeristy of Missouri-Kansas City
Kansas City, Missouri, 64108
About this study
Official title: Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
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.
Read the 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.
- Conditions
- Hemorrhagic Shock
- Being tested
- Glutamine, Ringer's Lactate, Placebo (for Glutamine)
- Keywords
- hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma
- Medical subject headings
- Shock, Hemorrhagic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Intravenous 25 grams once over 6 hours
Ringer's LactateDrug
Also called Lactated Rigner's (LR)
Intravenous 1 liter once over 6 hours
Placebo (for Glutamine)Drug
Given Intravenously in 1 liter Lactated Ringer's
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Lactate and Placebo for Glutamine | Placebo comparator | Ringer's Lactate 1 liter once over 6 hours Receives: Drug: Ringer's Lactate; Drug: Placebo (for Glutamine) |
| Ringer's Lactate with 25 grams Glutamine | Experimental | Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours Receives: Drug: Glutamine; Drug: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%. .
Measured: Change from Baseline in Cytokine Levels at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Charles Van Way, III, M.D., Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239680
- Sponsor's protocol ID
- 05-18
- Status last verified
- May 2014
- First submitted
- 12 Oct 2010
- Last updated
- 17 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
- ClinicalTrials.gov ID
- NCT01239680
- Acronym / sponsor ID
- 05-18
- Conditions
- Hemorrhagic Shock
- Keywords
- hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 17 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer's Lactate and Placebo for Glutamine | Placebo comparator | Drug: Ringer's Lactate, Drug: Placebo (for Glutamine)Ringer's Lactate 1 liter once over 6 hours |
| Ringer's Lactate with 25 grams Glutamine | Experimental | Drug: Glutamine, Drug: Ringer's LactateRinger's Lactate with 25 grams Glutamine (1 liter) once over 6 hours |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutamineIntravenous 25 grams once over 6 hours | Drug | Ringer's Lactate with 25 grams Glutamine |
| Ringer's LactateAlso: Lactated Rigner's (LR)Intravenous 1 liter once over 6 hours | Drug | Ringer's Lactate and Placebo for Glutamine, Ringer's Lactate with 25 grams Glutamine |
| Placebo (for Glutamine)Given Intravenously in 1 liter Lactated Ringer's | Drug | Ringer's Lactate and Placebo for Glutamine |
Primary outcome
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%. .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Van Way, III, M.D. principal investigator
University of Missouri, Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine and Ringer's Lactate in people with Hemorrhagic Shock, run by University of Missouri, Kansas City at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.