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临床试验/NCT02105415
NCT02105415已完成2 期

Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Mayo Clinic
入组人数
160
试验地点
1
主要终点
Mean Arterial Pressure

研究概览

简要总结

The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit. Patients that require a breathing tube to be placed in the ICU will be randomized to receIve either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the breathing tube.

详细描述

Endotracheal intubation is a procedure that may cause significant hemodynamic perturbations and can severely impact the outcome of the critically ill. To ensure a safe outcome during this particular procedure, there are many factors that the clinician is faced with. One decision that confronts the critical care physician involves the correct combination of medications with which to facilitate such a safe outcome. Given the reported hemodynamic stability, etomidate is a medication that is chosen by many providers in this particular situation. However, its association with a possible increase in mortality makes it less than ideal for a number of critical care physicians. In recent years, an admixture of propofol and ketamine has been studied that demonstrates hemodynamic stability based on the balancing of the hemodynamic effects of these two individual agents alone. This novel medication combination, sometimes referred to as "ketofol", may offer a valuable alternative to the critical care physician. Therefore, a randomized parallel-group clinical trial of adult critically ill patients admitted to a medical and/or surgical intensive care unit at Mayo Clinic Rochester who meet the criteria designated below for which urgent and/or emergent intubation is needed will receive one of two interventions based on stratified randomization. The "active" intervention arm will receive ketamine/propofol (ketofol) to facilitate endotracheal intubation. The comparison arm will receive etomidate. The primary outcome will focus on hemodynamic data recorded during the first 5 minutes post-administration with secondary outcomes looking at hemodynamic data at 10 and 15 minutes and addressing intensive care unit length of stay, mortality, adrenal function, and vasoactive medication use, among others.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Surgical or medical intensive care unity patients requiring endotracheal intubation
  • Consulting physician agrees to study plan and will follow drug randomization

排除标准

  • Known intracranial pathology
  • Known chronic opiate-dependence
  • Received continuous sedative infusion in the last 24 hours
  • Known severe psychiatric illness
  • Known egg allergies
  • Known contraindication to fentanyl, midazolam, ketamine, propofol or etomidate
  • Intubation in which standard practice is not to use sedation
  • No known documented weight or weight greater than 140 kg or less than 30 kg
  • Prior participation in the study
  • Of childbearing age (18-50) with no known negative pregnancy test on this admission.

研究组 & 干预措施

Ketamine / Propofol Admixture

Experimental

weight based dose of 0.5mg/kg of ketamine and 0.5mg/kg of propofol

干预措施: Ketamine / Propofol Admixture (Drug)

Etomidate

Active Comparator

weight based dose of 0.15mg/kg

干预措施: Etomidate (Drug)

结局指标

主要结局

Mean Arterial Pressure

时间窗: baseline and every 5 minutes up to 15 minutes minutes post study drug administration

Mean arterial pressure for the ketamine/propofol group at a 1:1 dose ratio compared to the etomidate group within the first 15 minutes post-administration in patients in need of urgent and/or emergent endotracheal intubation, as defined by any intubation within the intensive care unit excluding intubations for elective procedural events and codes.

次要结局

  • Mortality(Hospital Discharge or Day 28, whichever comes first)
  • Blood Product Transfusions(hospital discharge or day 28, whichever comes first)
  • Intensive Care Unit Free Days(hospital discharge or day 28, whichever comes first)
  • Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU(up to 24 hours post study drug administration)
  • Mechanical Ventilation Free Days(hospital discharge or day 28, whichever comes first)
  • Number of Participants With Adrenal Insufficiency(up to 24 hours post study drug administration)
  • Vasopressor Use(up to 24 hours post study drug administration)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan J. Smischney

PI

Mayo Clinic

研究点 (1)

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