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

NCT ID: NCT04408911

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Midazolam

Critically ill intensive care unit patients receiving midazolam

Midazolam vs. Lormetazepam

Intervention Type DRUG

In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.

Lormetazepam

Critically ill intensive care unit patients receiving lormetazepam

Midazolam vs. Lormetazepam

Intervention Type DRUG

In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.

Interventions

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Midazolam vs. Lormetazepam

In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Felix Balzer

Prof. Dr. med. Dr. rer. nat. Felix Balzer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RetroLoveMi

Identifier Type: -

Identifier Source: org_study_id