<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408911</url>
  </required_header>
  <id_info>
    <org_study_id>RetroLoveMi</org_study_id>
    <nct_id>NCT04408911</nct_id>
  </id_info>
  <brief_title>Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial</brief_title>
  <acronym>RetroLoveMi</acronym>
  <official_title>The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus&#xD;
      midazolam on hospital mortality, intensive care unit outcomes and sedation management.&#xD;
&#xD;
      The hypothesis is that patients receiving midazolam have a 5% higher hospital mortality in&#xD;
      comparison to patients receiving lormetazepam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sedation is an integral part of modern intensive care medicine and has seen a tremendous&#xD;
      development throughout the last years. Current guideline recommendations are targeted at an&#xD;
      awake critically ill patients (target Richmond Agitation-Sedation Scale 0/-1) as early deep&#xD;
      sedation has been shown to negatively affect the outcome. Nevertheless, is an adequate and&#xD;
      individualized anxiolysis still an important intervention that can be achieved via process&#xD;
      optimization, modifications to the infrastructure of the ward and pharmacologic therapy.&#xD;
      Bolus application of benzodiazepines is a recommended pharmacologic measure to achieve proper&#xD;
      anxiolysis. Midazolam is currently the most commonly used benzodiazepine in European&#xD;
      intensive care units. Midazolam accumulates after repetitive application due to its&#xD;
      pharmacokinetic properties, which increases the likelihood for side effects and makes&#xD;
      targeted sedation increasingly difficult. Lormetazepam is used with increasing frequency as&#xD;
      it is eliminated independent of the patients age and has few relevant metabolites. It is&#xD;
      therefore thought to be better suited for targeted sedation management, which in turn would&#xD;
      be beneficial for the patients.&#xD;
&#xD;
      The aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus&#xD;
      midazolam on hospital mortality, intensive care unit outcomes and sedation management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>On average 20 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Proportion of patients that between hospital admission and hospital discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of delirium during the intensive care unit stay</measure>
    <time_frame>On average 7 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Incidence of delirium diagnosed on the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of delirium during the intensive care unit stay</measure>
    <time_frame>On average 3 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Duration patients had a delirium on the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>On average 30 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Time patients spend admitted to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay</measure>
    <time_frame>On average 7 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Time patients spend admitted to the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>On average 4 days, for each study subject measured up to study completion day 12-31-2018</time_frame>
    <description>Time patients are mechanically ventilated</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3314</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <description>Critically ill intensive care unit patients receiving midazolam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lormetazepam</arm_group_label>
    <description>Critically ill intensive care unit patients receiving lormetazepam</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam vs. Lormetazepam</intervention_name>
    <description>In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.</description>
    <arm_group_label>Lormetazepam</arm_group_label>
    <arm_group_label>Midazolam</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intensive care unit patients at the Charité - Universitätsmedizin Berlin that received&#xD;
        either midazolam or lormetazepam.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intensive care unit patients at the Charité - Universitätsmedizin Berlin&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Intensive care unit length of stay ≥ 48 hours&#xD;
&#xD;
          -  Duration of mechanical ventilation &gt; 0 hours&#xD;
&#xD;
          -  Midazolam or lormetazepam application during the ICU stay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Number of application &lt; 2&#xD;
&#xD;
          -  Midazolam and lormetazepam application during the intensive care unit stay&#xD;
&#xD;
          -  Neurosurgical intensive care unit patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Felix Balzer</investigator_full_name>
    <investigator_title>Prof. Dr. med. Dr. rer. nat. Felix Balzer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Lormetazepam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408911
org study id: RetroLoveMi
nct id: NCT04408911
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Hospital Mortality
time frame: On average 20 days, for each study subject measured up to study completion day 12-31-2018
description: Proportion of patients that between hospital admission and hospital discharge
measure: 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
description: Incidence of delirium diagnosed on the intensive care unit
measure: 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
description: Duration patients had a delirium on the intensive care unit
measure: Hospital length of stay
time frame: On average 30 days, for each study subject measured up to study completion day 12-31-2018
description: Time patients spend admitted to the hospital
measure: 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
description: Time patients spend admitted to the intensive care unit
measure: Duration of mechanical ventilation
time frame: On average 4 days, for each study subject measured up to study completion day 12-31-2018
description: Time patients are mechanically ventilated
arm group label: Midazolam
description: Critically ill intensive care unit patients receiving midazolam
arm group label: Lormetazepam
description: Critically ill intensive care unit patients receiving lormetazepam
intervention type: Drug
intervention name: Midazolam vs. Lormetazepam
description: In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.
arm group label: Lormetazepam
arm group label: Midazolam
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Felix Balzer
investigator title: Prof. Dr. med. Dr. rer. nat. Felix Balzer
mesh term: Critical Illness
mesh term: Midazolam
mesh term: Lormetazepam
sharing ipd: No