Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial
- Registration Number
- NCT04408911
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3314
- 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
- Number of application < 2
- Midazolam and lormetazepam application during the intensive care unit stay
- Neurosurgical intensive care unit patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lormetazepam Midazolam vs. Lormetazepam Critically ill intensive care unit patients receiving lormetazepam Midazolam Midazolam vs. Lormetazepam Critically ill intensive care unit patients receiving midazolam
- Primary Outcome Measures
Name Time Method Hospital Mortality 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
- Secondary Outcome Measures
Name Time Method 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 Incidence of delirium diagnosed on the intensive care unit
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 Duration patients had a delirium on the intensive care unit
Intensive care unit length of stay On average 7 days, for each study subject measured up to study completion day 12-31-2018 Time patients spend admitted to the intensive care unit
Duration of mechanical ventilation On average 4 days, for each study subject measured up to study completion day 12-31-2018 Time patients are mechanically ventilated
Hospital length of stay On average 30 days, for each study subject measured up to study completion day 12-31-2018 Time patients spend admitted to the hospital