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临床试验/NCT01676454
NCT01676454撤回不适用

Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.

Poudre Valley Health System1 个研究点 分布在 1 个国家开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Serum vasopressin levels.

研究概览

简要总结

The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

详细描述

For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. This suggests that at least some patients suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and notable research consortiums have suggested that AVP shows promise for human resuscitation and have called for further human studies.

This is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ARDS, and sepsis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients with a minor injury or injuries, defined as:
  • no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission;
  • no blood transfusion requirement;
  • base deficit < 5 mEq/L;
  • no requirement for mechanical ventilation other than transiently during orthopedic surgery.

排除标准

  • corticosteroid use,
  • prisoners, and/or
  • head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or
  • evidence of spinal cord injury (another cause of vasodilatory shock).
  • Patients will also be excluded if pre-hospital provider information cannot be obtained, or indicates that the trauma occurred more than one 1 hour prior to emergency department admission.

结局指标

主要结局

Serum vasopressin levels.

时间窗: 24 hours.

6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Dunn, M.D.

Principal Investigator

Poudre Valley Health System

研究点 (1)

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