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临床试验/NCT02033733
NCT02033733Unknown不适用

Post-arrest Therapeutic Hypothermia. Does Use of Neuromuscular Blockers Achieve Faster Cooling Time?

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014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
入组人数
400
试验地点
2
主要终点
Time to attaining target temperature (hours).

研究概览

简要总结

After successful resuscitation from cardiac arrest, cooling the whole body is a well established treatment that improves the chances of the brain recovering. This however, has to be done within a certain time-frame from the arrest. The purpose of this study is to explore the best way of dosing the muscle relaxing medications that are given during the cooling process.

Hypothesis: In the context of our institutional therapeutic hypothermia protocol, cisatracurium infusions lead to faster drops in core temperature when compared to cisatracurium prn boluses alone.

详细描述

STUDY RATIONALE:

A large proportion of comatose survivors of cardiac arrest presenting to our intensive care units at London Health Sciences Centre (LHSC) undergo therapeutic hypothermia. Current evidence suggests that timely achievement of target temperatures is desirable to improve outcomes. At LHSC, this intervention is protocolized with a defined set of preprinted orders that includes a dosing regimen for neuromuscular blocking agents (NMBA's). Our preprinted protocol has been in place since January of 2004. Cisatracurium infusions were part of the therapeutic hypothermia protocol until October 2011. Since that time, our protocol has changed to cisatracurium prn boluses for any observed shivering. In this study we will examine if there has been any change in the times to achieving target temperatures with the implementation of this change. It is important to note that no other change in our protocol has taken place since it was first implemented, making our before and after comparison valid and fair.

Our hypothesis is that NMBA infusions lead to a faster drop in core temperatures when compared to NMBA prn boluses. If this were to stand true, we would expect cisatracurium IV infusions to result in faster reductions in core temperature when compared with cisatracurium prn boluses in the context of our therapeutic hypothermia protocol. Hypothermia has been known to cause a subclinical increase in muscle tone. This previously reported phenomenon has been named "microshivering". When attempting to reduce core temperatures, microshivering is likely a natural body response to try to restore body temperature back to normal. We therefore hypothesize that NMBA infusions are likely more effective at abolishing microshivering, which would be a desirable effect when trying to induce therapeutic hypothermia.

Although current American Heart Association (AHA) guidelines suggest considering the administration of NMBA's to facilitate induced hypothermia and control shivering. Their recommendation is to minimize the duration of NMBA use or if possible, avoid them altogether. After the publication of these guidelines our institutional protocol changed to prn boluses instead of the previous infusion orders. We therefore believe it is important to examine the effects of this change on our cooling protocol and potentially add to the growing body of knowledge in this field.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to adult ICU (age ≥18 years) at London Health Sciences Centre
  • Primary reason for ICU admission: postcardiac arrest
  • Both in-hospital and out-of-hospital cardiac arrest will be included
  • ICU admission between Jan 2008 and Dec 2012.

排除标准

  • ICU admissions primarily for reasons other than cardiac arrest.

研究组 & 干预措施

Adequate cooling time

Patients that reached target temperature within 4 hours of initiation of the hypothermia protocol will be in the "adequate cooling time" group.

干预措施: Cisatracurium infusion (Drug)

Adequate cooling time

Patients that reached target temperature within 4 hours of initiation of the hypothermia protocol will be in the "adequate cooling time" group.

干预措施: Cisatracurium prn bolus (Drug)

Inadequate cooling time

Patients that did not reach target temperature within 4 hours of initiation of the hypothermia protocol will be in the "inadequate cooling time" group.

干预措施: Cisatracurium infusion (Drug)

Inadequate cooling time

Patients that did not reach target temperature within 4 hours of initiation of the hypothermia protocol will be in the "inadequate cooling time" group.

干预措施: Cisatracurium prn bolus (Drug)

结局指标

主要结局

Time to attaining target temperature (hours).

时间窗: From initiation of hypothermia protocol to reaching a core body temperature of ≤34ºC, assessed up to 72 hours from protocol initiation.

The primary outcome will be a binary outcome that is: adequate cooling time versus inadequate cooling time based on the time needed to achieve target temperatures. We will define adequate cooling time as being ≤ 4 hours from initiation of protocol to reaching target temperature. Inadequate cooling time will be requiring \> 4 hours to achieve that goal. Target core body temperature range in our institutional protocol is 32 - 34ºC. The primary outcome will be assessed using a logistic regression model, constructed using covariates affecting speed of cooling as determined by expert opinion and current evidence apriori. The variables will be age, sex, weight, pre-protocol core body temperature, initial arrest rhythm and infusion versus boluses. The model will be used to determine whether the cisatracurium dosing regimen is an independent predictor of adequate patient cooling time or not.

次要结局

  • Cerebral performance category score on hospital discharge.(Upon discharge from hospital, assessed up to 36 months postcardiac arrest.)
  • Hospital length of stay postcardiac arrest (days).(Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest)
  • Intensive care unit length of stay postcardiac arrest (days).(Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest.)

研究者

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

Eyad AlThenayan

Dr. Eyad AlThenayan

University of Western Ontario, Canada

研究点 (2)

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