Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial (RetroLoveMi)

Charité University Medicine Berlin

Status: Completed

Conditions: Critical Illness

Treatments: Drug: Midazolam vs. Lormetazepam

Study type: Observational

Funder types: Other

Identifiers

NCT04408911

RetroLoveMi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,314 participants in 2 patient groups

Midazolam

Description:

Critically ill intensive care unit patients receiving midazolam

Treatment:

Drug: Midazolam vs. Lormetazepam

Lormetazepam

Description:

Critically ill intensive care unit patients receiving lormetazepam

Treatment:

Drug: Midazolam vs. Lormetazepam