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临床试验/NCT01239680
NCT01239680已完成不适用

Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy.

University of Missouri, Kansas City2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Ringer's Lactate and Placebo for Glutamine

Placebo Comparator

Ringer's Lactate 1 liter once over 6 hours

干预措施: Ringer's Lactate (Drug)

Ringer's Lactate and Placebo for Glutamine

Placebo Comparator

Ringer's Lactate 1 liter once over 6 hours

干预措施: Placebo (for Glutamine) (Drug)

Ringer's Lactate with 25 grams Glutamine

Experimental

Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours

干预措施: Glutamine (Drug)

Ringer's Lactate with 25 grams Glutamine

Experimental

Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours

干预措施: Ringer's Lactate (Drug)

结局指标

主要结局

Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).

时间窗: 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%. .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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