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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

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ClinicalTrials.gov Identifier: NCT01239680
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Missouri, Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hemorrhagic Shock
Interventions Drug: Glutamine
Drug: Ringer's Lactate
Drug: Placebo (for Glutamine)
Enrollment 5

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.
Pre-assignment Details  
Arm/Group Title Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Glutamine: Intravenous 25 Grams Once Over 6 Hours
Hide 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
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Glutamine: Intravenous 25 Grams Once Over 6 Hours Total
Hide 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 Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Age 21-65 Number Analyzed 3 participants 2 participants 5 participants
3 2 5
[1]
Measure Description: Age 21 to 65 years.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
2
 100.0%
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3 2 5
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).
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Glutamine: Intravenous 25 Grams Once Over 6 Hours
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours Glutamine: Intravenous 25 Grams Once Over 6 Hours
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Charles W. Van Way, III, M.D.
Organization: Truman Medical Center
Phone: 816.235.2553
Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01239680     History of Changes
Other Study ID Numbers: 05-18
First Submitted: October 12, 2010
First Posted: November 11, 2010
Results First Submitted: December 30, 2013
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014