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临床试验/NCT04408911
NCT04408911已完成不适用

The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial

Charite University, Berlin, Germany0 个研究点目标入组 3,314 人开始时间: 2006年1月1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
入组人数
3,314
主要终点
Hospital Mortality

研究概览

简要总结

The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management.

The hypothesis is that patients receiving midazolam have a 5% higher hospital mortality in comparison to patients receiving lormetazepam.

详细描述

Sedation is an integral part of modern intensive care medicine and has seen a tremendous development throughout the last years. Current guideline recommendations are targeted at an awake critically ill patients (target Richmond Agitation-Sedation Scale 0/-1) as early deep sedation has been shown to negatively affect the outcome. Nevertheless, is an adequate and individualized anxiolysis still an important intervention that can be achieved via process optimization, modifications to the infrastructure of the ward and pharmacologic therapy. Bolus application of benzodiazepines is a recommended pharmacologic measure to achieve proper anxiolysis. Midazolam is currently the most commonly used benzodiazepine in European intensive care units. Midazolam accumulates after repetitive application due to its pharmacokinetic properties, which increases the likelihood for side effects and makes targeted sedation increasingly difficult. Lormetazepam is used with increasing frequency as it is eliminated independent of the patients age and has few relevant metabolites. It is therefore thought to be better suited for targeted sedation management, which in turn would be beneficial for the patients.

The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management.

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

入选标准

  • Intensive care unit patients at the Charité - Universitätsmedizin Berlin
  • Age ≥ 18 years
  • Intensive care unit length of stay ≥ 48 hours
  • Duration of mechanical ventilation > 0 hours
  • Midazolam or lormetazepam application during the ICU stay

排除标准

  • Number of application < 2
  • Midazolam and lormetazepam application during the intensive care unit stay
  • Neurosurgical intensive care unit patients

研究组 & 干预措施

Midazolam

Critically ill intensive care unit patients receiving midazolam

干预措施: Midazolam vs. Lormetazepam (Drug)

Lormetazepam

Critically ill intensive care unit patients receiving lormetazepam

干预措施: Midazolam vs. Lormetazepam (Drug)

结局指标

主要结局

Hospital Mortality

时间窗: On average 20 days, for each study subject measured up to study completion day 12-31-2018

Proportion of patients that between hospital admission and hospital discharge

次要结局

  • Incidence of delirium during the intensive care unit stay(On average 7 days, for each study subject measured up to study completion day 12-31-2018)
  • Duration of delirium during the intensive care unit stay(On average 3 days, for each study subject measured up to study completion day 12-31-2018)
  • Intensive care unit length of stay(On average 7 days, for each study subject measured up to study completion day 12-31-2018)
  • Duration of mechanical ventilation(On average 4 days, for each study subject measured up to study completion day 12-31-2018)
  • Hospital length of stay(On average 30 days, for each study subject measured up to study completion day 12-31-2018)

研究者

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

Felix Balzer

Prof. Dr. med. Dr. rer. nat. Felix Balzer

Charite University, Berlin, Germany

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