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临床试验/NCT03036202
NCT03036202已完成不适用

Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年6月26日最近更新:
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
发起方
入组人数
8
试验地点
1
主要终点
Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration

研究概览

简要总结

To determine the pharmacokinetics of epinephrine during cardiac arrest.

详细描述

The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest, following a single dose of epinephrine. Venous samples will be withdrawn every minute the first five minutes following a single dose.

The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak concentration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-85 yrs
  • Witnessed non-traumatic cardiac arrest.
  • Probable cardiac origin
  • Treated by Bergen Emergency Medical Services

排除标准

  • Terminal illness
  • Residents of nursery homes
  • Obvious dead
  • Hypothermic patients
  • Epinephrine administered before arrival of study physician

研究组 & 干预措施

one group

All patients treated for cardiac arrest, meeting our inclusions criteria will be enrolled in the study. No interventions regarding the national guidelines will be jeopardized, as the plasma concentration following a single dose of epinephrine will be measured in all patient.

干预措施: Epinephrine (Drug)

结局指标

主要结局

Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration

时间窗: Blood samples will be drawn within minutes, and the survivors transported to hospital. The data according to Utstein-style, will also be collected. Blood samples will be analysed within weeks.Total timeframe for the study is estimated to one year.

Blood concentration of epinephrine will be determined the first five minutes following administration. For every minute starting With administration of epinephrine, blood samples will be drawn to determine the concentration (ng/mL). In total, six samples will be drawn. The administered dose (1 mg) will also be related to the patients weight, either estimated, or for those survivors admitted to hospital, measured in the Intensive Care Unit. Further, data according to the Utstein-template will be recorded.However, the primary outcome is to determine the plasma concentrations in every patients the first five minutes.

次要结局

未报告次要终点

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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