Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

NCT01239680 | Completed Results

• 1 other identifier: 05-18
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhagic Shock

Keywords

hemorrhagic shock; glutamine; trauma resuscitation; department of defense; trauma

Outcome Measures

Primary Outcomes (1)

• 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%. .

  Change from Baseline in Cytokine Levels at 24 hours

Study Arms (2)

Ringer's Lactate and Placebo for Glutamine

PLACEBO COMPARATOR

Ringer's Lactate 1 liter once over 6 hours

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

Drug: Glutamine; Drug: Ringer's Lactate

Interventions

Glutamine DRUG

Intravenous 25 grams once over 6 hours

Ringer's Lactate with 25 grams Glutamine

Ringer's Lactate DRUG

Intravenous 1 liter once over 6 hours

Also known as: Lactated Rigner's (LR)

Ringer's Lactate and Placebo for Glutamine; Ringer's Lactate with 25 grams Glutamine

Placebo (for Glutamine) DRUG

Given Intravenously in 1 liter Lactated Ringer's

Ringer's Lactate and Placebo for Glutamine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• United States Department of Defense: collaborator

Study Sites (2)

Truman Medical Center-Hospital Hill

Kansas City, Missouri, 64108, United States

Location

Univeristy of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Shock, Hemorrhagic; Wounds and Injuries

Interventions

Glutamine; Ringer's Lactate

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and 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.

Results Point of Contact

• Title: Charles W. Van Way, III, M.D.
• Organization: Truman Medical Center

vanwayc@umkc.edu

816.235.2553

Study Officials

• Charles Van Way, III, M.D.

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: November 11, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

US (2)