The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial
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
- 否
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
Felix Balzer
Prof. Dr. med. Dr. rer. nat. Felix Balzer
Charite University, Berlin, Germany
