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

NCT04408911 | Completed

• 1 other identifier: RetroLoveMi
• Study Type: observational
• Target: 3,314
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Hospital length of stay

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

• Intensive care unit length of stay

  On average 7 days, for each study subject measured up to study completion day 12-31-2018

• Duration of mechanical ventilation

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

Study Arms (2)

Midazolam

Critically ill intensive care unit patients receiving midazolam

Drug: Midazolam vs. Lormetazepam

Lormetazepam

Critically ill intensive care unit patients receiving lormetazepam

Drug: Midazolam vs. Lormetazepam

Interventions

Midazolam vs. Lormetazepam DRUG

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

Lormetazepam; Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Number of application \< 2
• Midazolam and lormetazepam application during the intensive care unit stay
• Neurosurgical intensive care unit patients

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Dr. rer. nat. Felix Balzer

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 29, 2020
• Study Start: January 1, 2006
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share