Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

• Sponsor: University of Missouri, Kansas City (Other)
• Overall Status: Completed
• CT.gov ID: NCT01239680
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 5
• Locations: 2
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhagic Shock	Drug: Glutamine; Drug: Ringer's Lactate; Drug: Placebo (for Glutamine)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Ringer's Lactate and Placebo for Glutamine Ringer's Lactate 1 liter once over 6 hours	Drug: Ringer's Lactate; Intravenous 1 liter once over 6 hours; Other Names: Lactated Rigner's (LR) ; Drug: Placebo (for Glutamine); 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	Drug: Glutamine; Intravenous 25 grams once over 6 hours; Drug: Ringer's Lactate; Intravenous 1 liter once over 6 hours; Other Names: Lactated Rigner's (LR)

Outcome Measures

Primary Outcome Measures

1. 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%. .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Truman Medical Center-Hospital Hill	Kansas City	Missouri	United States	64108
2	Univeristy of Missouri-Kansas City	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• University of Missouri, Kansas City
• United States Department of Defense

Investigators

• Principal Investigator: Charles Van Way, III, M.D., University of Missouri, Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Missouri, Kansas City
• ClinicalTrials.gov Identifier: NCT01239680
• Other Study ID Numbers: 05-18
• First Posted: Nov 11, 2010
• Last Update Posted: Jun 17, 2014
• Last Verified: May 1, 2014

• Keywords provided by University of Missouri, Kansas City: hemorrhagic shock; glutamine; trauma resuscitation; department of defense; trauma
• Additional relevant MeSH terms: Shock, Hemorrhagic; Wounds and Injuries

Study Results

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.

Arm/Group Title	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours
Arm/Group Description	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	Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
Period Title: Overall Study
STARTED	3	2
COMPLETED	1	2
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours	Total
Arm/Group Description	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	Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours	Total of all reporting groups
Overall Participants	3	2	5
Age, Customized (participants) [Number]
Age 21-65	3 100%	2 100%	5 100%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	3 100%	2 100%	5 100%
Region of Enrollment (participants) [Number]
United States	3 100%	2 100%	5 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants who had an intervention and completed the study with all 3 required blood draws.

Arm/Group Title	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours	Glutamine: Intravenous 25 Grams Once Over 6 Hours
Arm/Group Description	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.	Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
Measure Participants	0	0

Adverse Events

Time Frame	4 years total.
Adverse Event Reporting Description	Each study subjects was followed and assessed for Adverse events while enrolled in the study.
Arm/Group Title	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours		Glutamine: Intravenous 25 Grams Once Over 6 Hours
Arm/Group Description	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.		Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
All Cause Mortality
	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours		Glutamine: Intravenous 25 Grams Once Over 6 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours		Glutamine: Intravenous 25 Grams Once Over 6 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours		Glutamine: Intravenous 25 Grams Once Over 6 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)

Limitations/Caveats

Many subjects excluded due to being unstable after initial resuscitation, having altered mental status, inability to speak English, <21 years of age, or blood alcohol in excess of 80mg/dl. No waiver of consent.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.