Cardiogenic ShockLEVO-ECMONCT03346824
Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study
An observational study of Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to Jan 2019
- 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
- Adult, Older adult
Study population: Patient who required the use of short-term assistance
Who may be able to join
- Age over 18
- Patient requiring the need for short-term assistance
- Patient who has agreed to use his medical data for research purposes
Who cannot join
- Refusal to participate in the study
- Non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant
- Non-cardiac indications of assistance (indication of pulmonary replacement)
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Réanimation chirurgicale cardiovasculaire-NHC
Strasbourg, 67091
Gharib AJOB, MD, 33 3 69 55 15 70, gharib.ajob@chru-strasbourg.fr
Guillaume HAFFNER, MD, 33 3 69 55 15 70, guillaume.haffner@chru-strasbourg.fr
About this study
Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.
- Conditions
- Cardiogenic Shock
- Keywords
- Levosimendan, Veno-arterial ECMO, Weaning
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the incidence of weaning failure between patients with levosimendan and others
Measured: Data were recorded from admission until 48 hours after weaning from ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Nov 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (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 University Hospital, Strasbourg, 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346824
- Sponsor's protocol ID
- 6946
- Acronym
- LEVO-ECMO
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 27 Feb 2018
- 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 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03346824
- Acronym / sponsor ID
- LEVO-ECMO / 6946
- Conditions
- Cardiogenic Shock
- Keywords
- Levosimendan, Veno-arterial ECMO, Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 17 Nov 2017 (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.
Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient who required the use of short-term assistance
Key inclusion criteria (3 listed)
- Age over 18
- Patient requiring the need for short-term assistance
- Patient who has agreed to use his medical data for research purposes
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant
- Non-cardiac indications of assistance (indication of pulmonary replacement)
- Subject under guardianship or curatorship
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
Comparison of the incidence of weaning failure between patients with levosimendan and others
Time frame: Data were recorded from admission until 48 hours after weaning from ECMO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
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, run by University Hospital, Strasbourg, France 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 3 inclusion and 4 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 27 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gharib AJOB, MD (33 3 69 55 15 70, gharib.ajob@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the incidence of weaning failure between patients with levosimendan and others (time frame: Data were recorded from admission until 48 hours after weaning from ECMO). 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 27 Feb 2018.