EMCO-VAECMOVISNCT05412303
Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.
An observational study of EMCO-VA, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EMCO-VA
- What is being tested?
- data collection
- How many people
- 2,769 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 31 Dec 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: Post cardiotomy cardiogenic shock
Who may be able to join
- age over 18 years
- Cardiac surgery with cardiopulmonary bypass
- Post cardiotomy cardiogenic shock
- ECMO-VA implanted in OR
Who cannot join
- LVAD
- Heart transplantation
- Incomplete data in relation to outcomes
- Cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.
Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.
- Conditions
- EMCO-VA
- Being tested
- data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
age, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital
| Study group | Role | What they receive |
|---|---|---|
| With ECMO-VA | postcardiotomy cardiogenic shosck supported by ECMO-VA Receives: Other: data collection | |
| Without ECMO-VA | Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pourcentage of death
Measured: Day 30
Secondary outcomes (3)
1 - Number of complications
1- cardiac, neurological, renal, respiratory, red blood transfusion complication
Measured: Day 30
2 - number of days in intensive care
Measured: through study completion, up to 15 days
3 - number of days in hospital
Measured: through study completion, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 EMCO-VAStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412303
- Sponsor's protocol ID
- GUINOT 2022
- Acronym
- ECMOVIS
- Status last verified
- Jul 2026
- First submitted
- 23 May 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caruso V, Berthoud V, Bouchot O, Nguyen M, Bouhemad B, Guinot PG; ECMOVIS Study Group. Should the Vasoactive Inotropic Score be a Determinant for Early Initiation of VA ECMO in Postcardiotomy Cardiogenic Shock? J Cardiothorac Vasc Anesth. 2024 Mar;38(3):724-730. doi: 10.1053/j.jvca.2023.11.040. Epub 2023 Dec 1.
PubMed 38182434
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.
- ClinicalTrials.gov ID
- NCT05412303
- Acronym / sponsor ID
- ECMOVIS / GUINOT 2022
- Conditions
- EMCO-VA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,769 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jun 2022 (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 well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.
Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With ECMO-VA | – | Other: data collectionpostcardiotomy cardiogenic shosck supported by ECMO-VA |
| Without ECMO-VA | – | Other: data collectionPost cardiotomy cardiogenic shock medically treated (inotrope and vasopressor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post cardiotomy cardiogenic shock
Key inclusion criteria (4 listed)
- age over 18 years
- Cardiac surgery with cardiopulmonary bypass
- Post cardiotomy cardiogenic shock
- ECMO-VA implanted in OR
Key exclusion criteria (4 listed)
- LVAD
- Heart transplantation
- Incomplete data in relation to outcomes
- Cardiac arrest
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 collectionage, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital | Other | With ECMO-VA, Without ECMO-VA |
Primary outcome
Pourcentage of death
Time frame: Day 30
3 secondary outcomes
1 - Number of complications
Time frame: Day 30
2 - number of days in intensive care
Time frame: through study completion, up to 15 days
3 - number of days in hospital
Time frame: through study completion, up to 3 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 16 Jul 2026.
- Results publication: PubMed 38182434Caruso V, Berthoud V, Bouchot O, Nguyen M, Bouhemad B, Guinot PG; ECMOVIS Study Group. Should the Vasoactive Inotropic Score be a Determinant for Early Initiation of VA ECMO in Postcardiotomy Cardiogenic Shock? J Cardiothorac Vasc Anesth. 2024 Mar;38(3):724-730. doi: 10.1053/j.jvca.2023.11.040. Epub 2023 Dec 1.
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 EMCO-VA, run by Centre Hospitalier Universitaire Dijon 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 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: finished, as of the sponsor's last update on 16 Jul 2026. 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?
Pourcentage of death (time frame: Day 30). 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 NCT05412303, 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 16 Jul 2026.