Critical IllnessRetroLoveMiNCT04408911
Lormetazepam Versus Midazolam in Critically Ill Patients: a Retrospective Cohort Trial
An observational study of Critical Illness, run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Midazolam vs. Lormetazepam
- How many people
- 3,314 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients at the Charité - Universitätsmedizin Berlin that received either midazolam or lormetazepam.
Who may be able to join
- 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
Who cannot join
- Number of application < 2
- Midazolam and lormetazepam application during the intensive care unit stay
- Neurosurgical intensive care unit patients
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Midazolam vs. Lormetazepam
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam vs. LormetazepamDrug
In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Critically ill intensive care unit patients receiving midazolam Receives: Drug: Midazolam vs. Lormetazepam | |
| Lormetazepam | Critically ill intensive care unit patients receiving lormetazepam Receives: Drug: Midazolam vs. Lormetazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
Proportion of patients that between hospital admission and hospital discharge
Measured: 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
Incidence of delirium diagnosed on the intensive care unit
Measured: 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
Duration patients had a delirium on the intensive care unit
Measured: On average 3 days, for each study subject measured up to study completion day 12-31-2018
Hospital length of stay
Time patients spend admitted to the hospital
Measured: On average 30 days, for each study subject measured up to study completion day 12-31-2018
Intensive care unit length of stay
Time patients spend admitted to the intensive care unit
Measured: On average 7 days, for each study subject measured up to study completion day 12-31-2018
Duration of mechanical ventilation
Time patients are mechanically ventilated
Measured: On average 4 days, for each study subject measured up to study completion day 12-31-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2006
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408911
- Sponsor's protocol ID
- RetroLoveMi
- Acronym
- RetroLoveMi
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lormetazepam Versus Midazolam in Critically Ill Patients on Hospital Mortality: a Retrospective Cohort Trial
- ClinicalTrials.gov ID
- NCT04408911
- Acronym / sponsor ID
- RetroLoveMi / RetroLoveMi
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,314 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | – | Drug: Midazolam vs. LormetazepamCritically ill intensive care unit patients receiving midazolam |
| Lormetazepam | – | Drug: Midazolam vs. LormetazepamCritically ill intensive care unit patients receiving lormetazepam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients at the Charité - Universitätsmedizin Berlin that received either midazolam or lormetazepam.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Number of application < 2
- Midazolam and lormetazepam application during the intensive care unit stay
- Neurosurgical intensive care unit patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam vs. LormetazepamIn this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam. | Drug | Lormetazepam, Midazolam |
Primary outcome
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
5 secondary outcomes
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
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
Hospital length of stay
Time frame: 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
Duration of mechanical ventilation
Time frame: On average 4 days, for each study subject measured up to study completion day 12-31-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: On average 20 days, for each study subject measured up to study completion day 12-31-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.