Skip to main content
OpenTrials
Completed

NCT Number: NCT04408911

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam vs. Lormetazepam

Drug

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

Primary outcomes

  1. Hospital Mortality

    Time frame: 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 outcomes

  1. Incidence of delirium during the intensive care unit stay

    Time frame: 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

  2. Duration of delirium during the intensive care unit stay

    Time frame: 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

  3. Hospital length of stay

    Time frame: On average 30 days, for each study subject measured up to study completion day 12-31-2018

    Time patients spend admitted to the hospital

  4. Intensive care unit length of stay

    Time frame: 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

  5. Duration of mechanical ventilation

    Time frame: On average 4 days, for each study subject measured up to study completion day 12-31-2018

    Time patients are mechanically ventilated

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: RetroLoveMi

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.