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

May 28, 2020 updated by: Felix Balzer, Charite University, Berlin, Germany

The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive care unit patients at the Charité - Universitätsmedizin Berlin that received either midazolam or lormetazepam.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Midazolam
Critically ill intensive care unit patients receiving midazolam
Drug: Midazolam vs. Lormetazepam
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
Drug: Midazolam vs. Lormetazepam
In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On average 20 days, for each study subject measured up to study completion day 12-31-2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On average 7 days, for each study subject measured up to study completion day 12-31-2018
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
On average 3 days, for each study subject measured up to study completion day 12-31-2018
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
On average 30 days, for each study subject measured up to study completion day 12-31-2018
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
On average 7 days, for each study subject measured up to study completion day 12-31-2018
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
On average 4 days, for each study subject measured up to study completion day 12-31-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RetroLoveMi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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