Cardiogenic ShockWEANECMONCT04323709
Levosimendan for Veno-arterial ECMO Weaning
An observational study of Cardiogenic Shock and Refractory Shock, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support that has been increasingly used over the last decade to restore and maintain adequate end-organ perfusion, with data suggesting improvement in outcome for patients with refractory cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Refractory Shock
- What is being tested?
- Data collection and Data analysis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Mar 2020
- 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: Investigators performed a retrospective single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan
Who may be able to join
- Age ≥18 years
- All consecutive patients admitted with VA-ECMO support for refractory cardiogenic shock
- All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
- Levosimendan administration was left to the discretion of the attending clinician
Who cannot join
- Age < 18 years
- VA-ECMO duration < 48h
- VA-ECMO for refractory cardiac arrest
- Right heart or veno-venous ECMO
- VA-ECMO for circulatory failure following lung transplant surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support that has been increasingly used over the last decade to restore and maintain adequate end-organ perfusion, with data suggesting improvement in outcome for patients with refractory cardiogenic shock. Nevertheless, VA-ECMO weaning should be questioned every day during patient's support. Indeed, studies have shown that the incidence of severe complications related to ECMO is associated with longer circulatory support duration. Inotropes such as dobutamine are currently used to improve myocardial contractility during VA-ECMO support with the aim to enhance left ventricular ejection, aortic valve opening and to shorten ECMO duration. However, many data suggest an increase in mortality related to predisposition to myocardial ischemia and arrythmias. Levosimendan is a calcium sensitizing inotropic agent with systemic, coronary and pulmonary vasodilatory properties and specific cardioprotective effect without increasing myocardial oxygen consumption. The use of levosimendan in patients undergoing VA-ECMO may therefore be of interest both to reduce the duration of mechanical support and to minimize severe complication with few data suggesting a potential benefit of levosimendan for VA-ECMO weaning and survival in post-cardiotomy low cardiac output syndrome with improvement of endothelial function and hemodynamics. Investigators therefore sought to investigate whether the use of levosimendan improves weaning for patients undergoing VA-ECMO support for refractory cardiogenic shock hospitalized in the surgical intensive care unit (ICU).
- Conditions
- Cardiogenic Shock, Refractory Shock
- Being tested
- Data collection, Data analysis
- Keywords
- Refractory cardiogenic shock, Levosimendan, VA-ECMO (Veno-Arterial ExtraCorporeal Membrane Oxygenation)
- Medical subject headings
- Shock, Cardiogenic, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Clinical data are collected from the medical record of the institution. At admission, date were collected on age, gender, body mass index, Simplified Acute Physiology Score II, Sequential Organ Failure Assessment, hypertension, diabetes, hypercholesterolemia, smoking, history of stroke or congestive heart failure, coronary or peripheral artery disease, renal failure with dialysis, Left Ventricular Ejection Fraction(LVEF), Tricuspid Annular Plane Systolic Excursion, mean arterial pressure, heart rate, central venous pressure, ScvO2, presence of an intra-aortic balloon pump and biochemical parameters. During hospitalization data were collected on reason for initiation of VA-ECMO and its characteristics (duration, type, flow L/min, RPM, FiO2), length of stay in ICU, catecholamines and inotropes maximal dose and length of administration, patients with heart transplantation or LVAD. In patients with levosimendan treatment, timing of administration regarding ECMO canulation was collected
Data analysisOther
Continuous variables were presented as mean ± standard deviation and compared using Student's t-test or Mann-Whitney U-test depending on their normality. Categorical variables were presented as counts and percentages and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Survival at day 28 was estimated using the Kaplan-Meier method and compared using the log rank test. Investigators conducted a multivariable logistic regression with propensity score matching, which was defined as the probability of exposure to levosimendan. Results were reported as odd ratios (ORs) together its 95%CI assuming a 5% level of statistical significance. All analyses were carried out using STATA 15.0 (Stata Corp, College Station, Texas 77845 USA).
| Study group | Role | What they receive |
|---|---|---|
| levosimendan group | All patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible. Receives: Other: Data collection; Other: Data analysis | |
| group control | All patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible. Receives: Other: Data collection; Other: Data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
VA-ECMO weaning failure defined as death
The primary endpoint was VA-ECMO weaning failure defined as death during ECMO support or death within 24h after ECMO removal.
Measured: 24 hours
Secondary outcomes (2)
Impact of exposure to levosimendan (at day 28)
Secondary endpoints were the impact of exposure to levosimendan on mortality at day 28 after VA-ECMO canulation.
Measured: Day 28
Impact of exposure to levosimendan (at 6 months)
Secondary endpoints were the impact of exposure to levosimendan on mortality at 6 months after VA-ECMO canulation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jan 2019
- Primary completion31 Jan 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323709
- Sponsor's protocol ID
- WEANECMO_2020
- Acronym
- WEANECMO
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guilherme E, Jacquet-Lagreze M, Pozzi M, Achana F, Armoiry X, Fellahi JL. Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis. Crit Care. 2020 Jul 16;24(1):442. doi: 10.1186/s13054-020-03122-y.
PubMed 32677985
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis
- ClinicalTrials.gov ID
- NCT04323709
- Acronym / sponsor ID
- WEANECMO / WEANECMO_2020
- Conditions
- Cardiogenic Shock, Refractory Shock
- Keywords
- Refractory cardiogenic shock, Levosimendan, VA-ECMO (Veno-Arterial ExtraCorporeal Membrane Oxygenation)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Mar 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.
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support that has been increasingly used over the last decade to restore and maintain adequate end-organ perfusion, with data suggesting improvement in outcome for patients with refractory cardiogenic shock. Nevertheless, VA-ECMO weaning should be questioned every day during patient's support. Indeed, studies have shown that the incidence of severe complications related to ECMO is associated with longer circulatory support duration. Inotropes such as dobutamine are currently used to improve myocardial contractility during VA-ECMO support with the aim to enhance left ventricular ejection, aortic valve opening and to shorten ECMO duration. However, many data suggest an increase in mortality related to predisposition to myocardial ischemia and arrythmias. Levosimendan is a calcium sensitizing inotropic agent with systemic, coronary and pulmonary vasodilatory properties and specific cardioprotective effect without increasing myocardial oxygen consumption. The use of levosimendan in patients undergoing VA-ECMO may therefore be of interest both to reduce the duration of mechanical support and to minimize severe complication with few data suggesting a potential benefit of levosimendan for VA-ECMO weaning and survival in post-cardiotomy low cardiac output syndrome with improvement of endothelial function and hemodynamics. Investigators therefore sought to investigate whether the use of levosimendan improves weaning for patients undergoing VA-ECMO support for refractory cardiogenic shock hospitalized in the surgical intensive care unit (ICU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levosimendan group | – | Other: Data collection, Other: Data analysisAll patients undergoing VA-ECMO from January 2012 to December 2018 and treated with levosimendan were eligible. |
| group control | – | Other: Data collection, Other: Data analysisAll patients undergoing VA-ECMO from January 2012 to December 2018 but not treated with levosimendan were eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators performed a retrospective single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan
Key inclusion criteria (4 listed)
- Age ≥18 years
- All consecutive patients admitted with VA-ECMO support for refractory cardiogenic shock
- All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
- Levosimendan administration was left to the discretion of the attending clinician
Key exclusion criteria (5 listed)
- Age < 18 years
- VA-ECMO duration < 48h
- VA-ECMO for refractory cardiac arrest
- Right heart or veno-venous ECMO
- VA-ECMO for circulatory failure following lung transplant surgery.
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 |
|---|---|---|
| Data collectionClinical data are collected from the medical record of the institution. At admission, date were collected on age, gender, body mass index, Simplified Acute Physiology Score II, Sequential Organ Failure Assessment, hypertension, diabetes, hypercholesterolemia, smoking, history of stroke or congestive heart failure, coronary or peripheral artery disease, renal failure with dialysis, Left Ventricular Ejection Fraction(LVEF), Tricuspid Annular Plane Systolic Excursion, mean arterial pressure, heart rate, central venous pressure, ScvO2, presence of an intra-aortic balloon pump and biochemical parameters. During hospitalization data were collected on reason for initiation of VA-ECMO and its characteristics (duration, type, flow L/min, RPM, FiO2), length of stay in ICU, catecholamines and inotropes maximal dose and length of administration, patients with heart transplantation or LVAD. In patients with levosimendan treatment, timing of administration regarding ECMO canulation was collected | Other | group control, levosimendan group |
| Data analysisContinuous variables were presented as mean ± standard deviation and compared using Student's t-test or Mann-Whitney U-test depending on their normality. Categorical variables were presented as counts and percentages and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Survival at day 28 was estimated using the Kaplan-Meier method and compared using the log rank test. Investigators conducted a multivariable logistic regression with propensity score matching, which was defined as the probability of exposure to levosimendan. Results were reported as odd ratios (ORs) together its 95%CI assuming a 5% level of statistical significance. All analyses were carried out using STATA 15.0 (Stata Corp, College Station, Texas 77845 USA). | Other | group control, levosimendan group |
Primary outcome
VA-ECMO weaning failure defined as death
Time frame: 24 hours
The primary endpoint was VA-ECMO weaning failure defined as death during ECMO support or death within 24h after ECMO removal.
2 secondary outcomes
Impact of exposure to levosimendan (at day 28)
Time frame: Day 28
Impact of exposure to levosimendan (at 6 months)
Time frame: 6 months
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 26 Mar 2020.
- Derived from this study: PubMed 32677985Guilherme E, Jacquet-Lagreze M, Pozzi M, Achana F, Armoiry X, Fellahi JL. Can levosimendan reduce ECMO weaning failure in cardiogenic shock?: a cohort study with propensity score analysis. Crit Care. 2020 Jul 16;24(1):442. doi: 10.1186/s13054-020-03122-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Refractory Shock, run by Hospices Civils de Lyon at 1 site in 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 4 inclusion and 5 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
VA-ECMO weaning failure defined as death (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323709, which also lists 1 linked publication.
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 26 Mar 2020.