Critical Illness Clinical Trial
Official title:
The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial
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.
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.
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