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Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT01239680
First received: October 12, 2010
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: December 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hemorrhagic Shock
Interventions: Drug: Glutamine
Drug: Ringer's Lactate
Drug: Placebo (for Glutamine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours 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
Glutamine: Intravenous 25 Grams 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

Participant Flow:   Overall Study
    Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours     Glutamine: Intravenous 25 Grams Once Over 6 Hours  
STARTED     3     2  
COMPLETED     1     2  
NOT COMPLETED     2     0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours 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
Glutamine: Intravenous 25 Grams 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 Total of all reporting groups

Baseline Measures
    Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours     Glutamine: Intravenous 25 Grams Once Over 6 Hours     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age, Customized [1]
[units: participants]
     
Age 21-65     3     2     5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  
[1] Age 21 to 65 years.



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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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
e-mail: vanwayc@umkc.edu


No publications provided


Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01239680     History of Changes
Other Study ID Numbers: 05-18
Study First Received: October 12, 2010
Results First Received: December 30, 2013
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board