N/A
N=5
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Hemorrhagic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01239680 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glutamine (Drug); Ringer's Lactate (Drug); Placebo (for Glutamine) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Missouri, Kansas City
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6). |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01239680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.