Clinical trial NCT04408911: Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial
Official title: The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 3314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit patients at the Charité - Universitätsmedizin Berlin that received either midazolam or lormetazepam.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Hospital Mortality
timeFrame: On average 20 days, for each study subject measured up to study completion day 12-31-2018
Secondary outcomes:
measure: Incidence of delirium during the intensive care unit stay
timeFrame: On average 7 days, for each study subject measured up to study completion day 12-31-2018
measure: Duration of delirium during the intensive care unit stay
timeFrame: On average 3 days, for each study subject measured up to study completion day 12-31-2018
measure: Hospital length of stay
timeFrame: On average 30 days, for each study subject measured up to study completion day 12-31-2018
measure: Intensive care unit length of stay
timeFrame: On average 7 days, for each study subject measured up to study completion day 12-31-2018
measure: Duration of mechanical ventilation
timeFrame: On average 4 days, for each study subject measured up to study completion day 12-31-2018
Other outcomes:
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