Cardiogenic ShockSeLeBêtaNCT04938375
Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study
An observational study of Cardiogenic Shock and Arrythmia, run by Central Hospital, Nancy, France.
Trial summary
The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Arrythmia
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jul 2021
- 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: Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment
Who may be able to join
- Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment
Who cannot join
- Patient's opposition
About this study
The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.
- Conditions
- Cardiogenic Shock, Arrythmia
- Medical subject headings
- Shock, Cardiogenic, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker
Incidence of adverse events leading to discontinuation of beta blocker: bradycardia/high-grade atrioventricular block/hypotension/noradrenaline increase/crystalloid resuscitation
Measured: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment
Secondary outcomes (1)
Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality
Description of adverse events related to beta blocker Efficacy of beta blocker (rhythm and/or rate control) Time to resolution after discontinuation of beta blocker in case of adverse event Maximum dosage of well-tolerated beta blocker; Evolution of the haemodynamic profile in the hours following the introduction of the beta blocker Resuscitation mortality Weaning from veno-arterial ECMO at D7 of Levosimendan treatment
Measured: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jan 2016
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938375
- Sponsor's protocol ID
- 2021PI069
- Acronym
- SeLeBêta
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04938375
- Acronym / sponsor ID
- SeLeBêta / 2021PI069
- Conditions
- Cardiogenic Shock, Arrythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 24 Jun 2021 (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 purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment
Key inclusion criteria (1 listed)
- Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment
Key exclusion criteria (1 listed)
- Patient's opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker
Time frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment
Incidence of adverse events leading to discontinuation of beta blocker: bradycardia/high-grade atrioventricular block/hypotension/noradrenaline increase/crystalloid resuscitation
1 secondary outcome
Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality
Time frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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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 Cardiogenic Shock and Arrythmia, run by Central Hospital, Nancy, France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jun 2021. 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?
Results are not available in the source record.
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?
To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker (time frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment). 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 24 Jun 2021.