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临床试验/NCT05264246
NCT05264246终止不适用

Evaluation of an Anti-Shivering Protocol for Targeted Temperature Management Following Cardiac Arrest

Methodist Health System1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
165
试验地点
1
主要终点
NMB usage

研究概览

简要总结

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019.

详细描述

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019. To allow for an adequate washout period, patients who were initiated on TTM before April 22, 2019 will be in the "before" group and patients initiated on TTM on or after June 1, 2019 will be in the "after" group. Patients will be identified based on electronic medical records search of order sets utilized in TTM and confirmed with manual chart review. Statistical analysis will be performed as detailed below.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age > 18 years
  • •Diagnosis of cardiac arrest
  • •Initiation of TTM via Arctic Sun® device

排除标准

  • •Initiation of TTM > 12 hours after cardiac arrest
  • •Receiving NMBs for an indication other than TTM
  • •Early termination of TTM (less than 24 hours)

结局指标

主要结局

NMB usage

时间窗: June 1, 2017 - May 31, 2021

vecuronium or cisatracurium

次要结局

  • ICU length of stay(June 1, 2017 - May 31, 2021)
  • Time to target temperature from initiation of TTM(June 1, 2017 - May 31, 2021)
  • NMB usage(June 1, 2017 - May 31, 2021)
  • Patients discharged home(June 1, 2017 - May 31, 2021)
  • Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation(First 72 hours of TTM initiation)
  • Proportion of patients cooled to 33°C versus 36°C(June 1, 2017 - May 31, 2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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