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

Critical Illness Clinical Trial

— RetroLoveMi  

Official title:

The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408911
• Other study ID #: RetroLoveMi
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3314
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Midazolam vs. Lormetazepam
In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	Proportion of patients that between hospital admission and hospital discharge	On average 20 days, for each study subject measured up to study completion day 12-31-2018
Secondary	Incidence of delirium during the intensive care unit stay	Incidence of delirium diagnosed on the intensive care unit	On average 7 days, for each study subject measured up to study completion day 12-31-2018
Secondary	Duration of delirium during the intensive care unit stay	Duration patients had a delirium on the intensive care unit	On average 3 days, for each study subject measured up to study completion day 12-31-2018
Secondary	Hospital length of stay	Time patients spend admitted to the hospital	On average 30 days, for each study subject measured up to study completion day 12-31-2018
Secondary	Intensive care unit length of stay	Time patients spend admitted to the intensive care unit	On average 7 days, for each study subject measured up to study completion day 12-31-2018
Secondary	Duration of mechanical ventilation	Time patients are mechanically ventilated	On average 4 days, for each study subject measured up to study completion day 12-31-2018