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临床试验/NCT04360070
NCT04360070招募中不适用

The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes

Fraser Health1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年2月28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
招募中
发起方
入组人数
24
试验地点
1
主要终点
Feasibility Data

研究概览

简要总结

Recent evidence suggests ketamine may attenuate harmful cellular cascades taking place after brain injury that result in permanent damage. The investigators are interested in researching the application of this in the setting of cardiac arrest. Following cardiac arrest, the brain is deprived oxygen for a period of time, leading to the imitation of these harmful cellular processes. The investigators hypothesize that patients who receive ketamine as part of their standard sedation procedures during cardiac arrest treatment have better neurological functioning compared to those who do not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • All out-of-hospital cardiac arrests (OHCA) with a "shockable rhythm" (ventricular fibrillation, pulseless ventricular tachycardia) that present to the Royal Columbian Hospital. The patient may be either in active cardiac arrest with shockable rhythm or may have achieved Return of Spontaneous Circulation (ROSC).
  • Over 19 years of age
  • Patients requiring sedation based on the assessment of the resuscitating physician.

排除标准

  • Any other type of cardiac arrest
  • Any history of previous, pre-existing neurological deficit
  • Started on Extracorporeal Membrane Oxygenation (ECMO)
  • Duration of cardiac arrest without ROSC is greater than 30 consecutive minutes
  • Known contraindication or hypersensitivity to ketamine
  • Awake patient or no standard sedation or no intubation required
  • Inability to obtain deferred consent
  • Currently enrolled in any other research study involving drugs or devices
  • Patients who are pregnant
  • Patients who are prisoners
  • Patients residing in Long Term Care (LTC) facilities

研究组 & 干预措施

Ketamine Arm

Experimental

Patients randomized to the ketamine arm will receive ketamine as part of their sedation medications during their cardiac arrest treatment

干预措施: Ketamine Hydrochloride (Drug)

结局指标

主要结局

Feasibility Data

时间窗: through study completion, an average of 6 months.

To test the appropriateness of the eligibility criteria by recording enrolment rates of eligible patients, test the randomization assignment procedures by evaluating for any difference in baseline characteristics between groups, and test adequate adherence to protocol by recording time taken to administer intervention during sedation procedures.

次要结局

未报告次要终点

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

George Medvedev

Head of Neurology

Fraser Health

研究点 (1)

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