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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Primary Purpose

Hemorrhagic Shock

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Ringer's Lactate
Placebo (for Glutamine)
Sponsored by
University of Missouri, Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock focused on measuring hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Truman Medical Center-Hospital Hill
  • Univeristy of Missouri-Kansas City

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Ringer's Lactate and Placebo for Glutamine

Ringer's Lactate with 25 grams Glutamine

Arm Description

Ringer's Lactate 1 liter once over 6 hours

Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours

Outcomes

Primary Outcome Measures

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%. .

Secondary Outcome Measures

Full Information

First Posted
October 12, 2010
Last Updated
May 14, 2014
Sponsor
University of Missouri, Kansas City
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01239680
Brief Title
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Official Title
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri, Kansas City
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock
Keywords
hemorrhagic shock, glutamine, trauma resuscitation, department of defense, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ringer's Lactate and Placebo for Glutamine
Arm Type
Placebo Comparator
Arm Description
Ringer's Lactate 1 liter once over 6 hours
Arm Title
Ringer's Lactate with 25 grams Glutamine
Arm Type
Experimental
Arm Description
Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
Intravenous 25 grams once over 6 hours
Intervention Type
Drug
Intervention Name(s)
Ringer's Lactate
Other Intervention Name(s)
Lactated Rigner's (LR)
Intervention Description
Intravenous 1 liter once over 6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo (for Glutamine)
Intervention Description
Given Intravenously in 1 liter Lactated Ringer's
Primary Outcome Measure Information:
Title
Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Van Way, III, M.D.
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Truman Medical Center-Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Univeristy of Missouri-Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

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