VA-ECMO for Postcardiotomy Cardiogenic ShockNCT07873034
Timing of VA-ECMO Support During or After Cardiac Surgery
An observational study of VA-ECMO for Postcardiotomy Cardiogenic Shock, run by National Institute of Cardiovascular Diseases, Slovakia at 1 site in Slovakia.
Trial summary
Some patients develop severe heart failure during or after cardiac surgery and require temporary support for circulation and oxygenation. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a form of life support that circulates blood outside the body through a pump and an oxygenator while the heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VA-ECMO for Postcardiotomy Cardiogenic Shock
- How many people
- 128 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2013to 30 Jun 2026
- 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: The study population consists of adult patients identified from institutional clinical records who received VA-ECMO for postcardiotomy cardiogenic shock. Patients of all sexes were eligible. Healthy volunteers were not included. Patients with hybrid configurations or subsequent configuration changes were included when these formed part of their VA-ECMO treatment for postcardiotomy cardiogenic shock.
Who may be able to join
- Age 18 years or older
- Cardiac surgery at the study center
- Postcardiotomy cardiogenic shock requiring VA-ECMO during the operation or after surgery
- Initiation of support between January 2013 and June 2026
Who cannot join
- Age younger than 18 years
- ECMO initiated for an indication unrelated to postcardiotomy cardiogenic shock
- Exclusively venovenous ECMO without an arterial circulatory support component
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
National Institute of Cardiovascular Diseases in Bratislava
Bratislava, 83347
About this study
Official title: Timing of Venoarterial Extracorporeal Membrane Oxygenation in Postcardiotomy Cardiogenic Shock: A Retrospective Single-Center Cohort Study
Some patients develop severe heart failure during or after cardiac surgery and require temporary support for circulation and oxygenation. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a form of life support that circulates blood outside the body through a pump and an oxygenator while the heart recovers.
This retrospective study examines 128 adults who received VA-ECMO for postcardiotomy cardiogenic shock at the National Institute for Cardiovascular Diseases in Bratislava, Slovakia, between January 2013 and June 2026. The study includes 78 patients who started support during the operation or because they could not be separated from cardiopulmonary bypass, and 50 patients who started support later in the intensive care unit after postoperative deterioration.
The main objective is to evaluate the association between the timing of VA-ECMO initiation and death before hospital discharge. Additional outcomes include successful removal of ECMO with survival for at least 24 hours after decannulation, duration of ECMO support, and length of hospitalization. Existing clinical records are used to account for measured differences in patient condition and surgical complexity. All treatment decisions were made by the treating clinical team during routine care.
Read the detailed description
This retrospective observational study evaluates the association between the timing of VA-ECMO initiation and in-hospital outcomes in adult patients with refractory postcardiotomy cardiogenic shock. The cohort comprises 128 patients treated at the Department of Cardiac Surgery, National Institute for Cardiovascular Diseases, Bratislava, Slovakia, between January 2013 and June 2026.
VA-ECMO was initiated for persistent circulatory failure during or after cardiac surgery despite optimization of preload, vasoactive and inotropic support, and correction of reversible causes. Initiation, cannulation strategy, ECMO configuration, and left-sided cardiac unloading were determined by the treating multidisciplinary team according to the patient's clinical condition. Treatment timing was not assigned by the study.
- Keywords
- VA-ECMO, Postcardiotomy cardiogenic shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative VA-ECMO | Initial VA-ECMO implantation during the cardiac operation or immediately following inability to separate from cardiopulmonary bypass. A total of 78 participants. | |
| Postoperative VA-ECMO | Initial VA-ECMO implantation in the intensive care unit following postoperative hemodynamic or respiratory deterioration after the cardiac operation. A total of 50 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause in-hospital mortality
Number and percentage of participants who died from any cause during the index hospitalization in which VA-ECMO was initiated. This includes death during ECMO support and death after ECMO discontinuation before hospital discharge. The denominator is the total number of participants in the respective timing group. Survival to hospital discharge is the complementary outcome.
Measured: From initial VA-ECMO initiation until death from any cause or discharge from the index hospitalization, whichever occurred for up to 37 days.
Secondary outcomes (3)
Successful ECMO weaning
Number and percentage of participants in whom ECMO was explanted or discontinued and who survived for at least 24 hours after decannulation. Death during ECMO support, inability to separate from ECMO, or death before completion of 24 hours after decannulation constitutes weaning failure. A subsequent death during the same hospitalization does not reverse successful weaning once the 24-hour survival criterion has been met. The denominator is the total number of participants in the respective timing group.
Measured: From initial VA-ECMO initiation through 24 hours after decannulation, or until death if earlier, during the index hospitalization, assessed up to 226 hours.
Duration of ECMO support
Duration of ECMO support in hours, measured from initiation to discontinuation of support or death during support. Duration is summarized as the median and interquartile range for each timing group, including participants who survived and those who died during support.
Measured: From initial VA-ECMO initiation until discontinuation of ECMO support or death during support, whichever occurred first, during the index hospitalization, assessed up to 250 hours.
Length of index hospitalization
Length of the index hospital stay in days, measured from hospital admission to hospital discharge or in-hospital death. Length of stay is summarized as the median and interquartile range for each timing group and includes both survivors and nonsurvivors.
Measured: From admission for the index hospitalization until hospital discharge or in-hospital death, whichever occurred first, assessed up to 37 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2013
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VA-ECMO for Postcardiotomy Cardiogenic ShockStudies of the same condition, open and under way.
- 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Slovakia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, assoc. prof. Panagiotis Artemiou, MD., PhD., National Institute of Cardiovascular Diseases, Slovakia
- Investigators
- Panagiotis Artemiou, assoc. prof., MD, PhD., Principal investigator, National Institute of Cardiovacsular Diseses in Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873034
- Sponsor's protocol ID
- VA-ECMO POSTCARShock
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research is part of a PhD thesis, which will be published in its entirety following its successful defense. Partial results have already been published (https://link.springer.com/article/10.1007/s44411-026-00733-9), while a manuscript presenting the overall results has been prepared and is currently under review.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Venoarterial Extracorporeal Membrane Oxygenation in Postcardiotomy Cardiogenic Shock: A Retrospective Single-Center Cohort Study
- ClinicalTrials.gov ID
- NCT07873034
- Acronym / sponsor ID
- VA-ECMO POSTCARShock
- Keywords
- VA-ECMO, Postcardiotomy cardiogenic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, SlovakiaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Oct 2026 (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.
Some patients develop severe heart failure during or after cardiac surgery and require temporary support for circulation and oxygenation. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a form of life support that circulates blood outside the body through a pump and an oxygenator while the heart recovers.
This retrospective study examines 128 adults who received VA-ECMO for postcardiotomy cardiogenic shock at the National Institute for Cardiovascular Diseases in Bratislava, Slovakia, between January 2013 and June 2026. The study includes 78 patients who started support during the operation or because they could not be separated from cardiopulmonary bypass, and 50 patients who started support later in the intensive care unit after postoperative deterioration.
The main objective is to evaluate the association between the timing of VA-ECMO initiation and death before hospital discharge. Additional outcomes include successful removal of ECMO with survival for at least 24 hours after decannulation, duration of ECMO support, and length of hospitalization. Existing clinical records are used to account for measured differences in patient condition and surgical complexity. All treatment decisions were made by the treating clinical team during routine care.
Detailed description
This retrospective observational study evaluates the association between the timing of VA-ECMO initiation and in-hospital outcomes in adult patients with refractory postcardiotomy cardiogenic shock. The cohort comprises 128 patients treated at the Department of Cardiac Surgery, National Institute for Cardiovascular Diseases, Bratislava, Slovakia, between January 2013 and June 2026.
VA-ECMO was initiated for persistent circulatory failure during or after cardiac surgery despite optimization of preload, vasoactive and inotropic support, and correction of reversible causes. Initiation, cannulation strategy, ECMO configuration, and left-sided cardiac unloading were determined by the treating multidisciplinary team according to the patient's clinical condition. Treatment timing was not assigned by the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative VA-ECMO | – | –Initial VA-ECMO implantation during the cardiac operation or immediately following inability to separate from cardiopulmonary bypass. A total of 78 participants. |
| Postoperative VA-ECMO | – | –Initial VA-ECMO implantation in the intensive care unit following postoperative hemodynamic or respiratory deterioration after the cardiac operation. A total of 50 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients identified from institutional clinical records who received VA-ECMO for postcardiotomy cardiogenic shock. Patients of all sexes were eligible. Healthy volunteers were not included. Patients with hybrid configurations or subsequent configuration changes were included when these formed part of their VA-ECMO treatment for postcardiotomy cardiogenic shock.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Cardiac surgery at the study center
- Postcardiotomy cardiogenic shock requiring VA-ECMO during the operation or after surgery
- Initiation of support between January 2013 and June 2026
Key exclusion criteria (3 listed)
- Age younger than 18 years
- ECMO initiated for an indication unrelated to postcardiotomy cardiogenic shock
- Exclusively venovenous ECMO without an arterial circulatory support component
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
All-cause in-hospital mortality
Time frame: From initial VA-ECMO initiation until death from any cause or discharge from the index hospitalization, whichever occurred for up to 37 days.
Number and percentage of participants who died from any cause during the index hospitalization in which VA-ECMO was initiated. This includes death during ECMO support and death after ECMO discontinuation before hospital discharge. The denominator is the total number of participants in the respective timing group. Survival to hospital discharge is the complementary outcome.
3 secondary outcomes
Successful ECMO weaning
Time frame: From initial VA-ECMO initiation through 24 hours after decannulation, or until death if earlier, during the index hospitalization, assessed up to 226 hours.
Duration of ECMO support
Time frame: From initial VA-ECMO initiation until discontinuation of ECMO support or death during support, whichever occurred first, during the index hospitalization, assessed up to 250 hours.
Length of index hospitalization
Time frame: From admission for the index hospitalization until hospital discharge or in-hospital death, whichever occurred first, assessed up to 37 days.
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 14 Oct 2026.
- direct link to the article with interim results of the workLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The research is part of a PhD thesis, which will be published in its entirety following its successful defense. Partial results have already been published (https://link.springer.com/article/10.1007/s44411-026-00733-9), while a manuscript presenting the overall results has been prepared and is currently under review.
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.
Panagiotis Artemiou, assoc. prof., MD, PhD. principal investigator
National Institute of Cardiovacsular Diseses in Bratislava, Slovakia
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 VA-ECMO for Postcardiotomy Cardiogenic Shock, run by National Institute of Cardiovascular Diseases, Slovakia at 1 site in Slovakia.
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 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 14 Oct 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 Slovakia. 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?
All-cause in-hospital mortality (time frame: From initial VA-ECMO initiation until death from any cause or discharge from the index hospitalization, whichever occurred for up to 37 days.). 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 14 Oct 2026.