Cardiogenic ShockECMO-CSNCT02301819
ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
A study testing Veno-arterial extracorporeal membrane oxygenation (ECMO) and Early conservative therapy according to standard practice in people with Cardiogenic Shock, run by Na Homolce Hospital at 4 sites in Czechia.
Trial summary
Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Veno-arterial extracorporeal membrane oxygenation (ECMO) and Early conservative therapy according to standard practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesCzechia
- Study dates
- Sep 2014to Jan 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients must fulfil criteria for rapidly deteriorating (A) or severe (B) cardiogenic shock:
- Rapidly deteriorating cardiogenic shock is defined as progressive hemodynamic instability necessitating repeated bolus administration of vasopressors to maintain mean arterial pressure > 50 mmHg + impaired left ventricle systolic function (Left ventricle ejection fraction (LVEF) < 35% or LVEF 35-55% in case of severe mitral regurgitation or aortic stenosis) or
- In severe cardiogenic shock all following criteria should be met:
- Hemodynamic:
- Cardiac Index (CI) < 2.2 L/min/m2 + norepinephrine dose > 0.1 μg/kg/min + dobutamin dose > 5 μg/kg/min or Systolic blood pressure < 100 mmHg + norepinephrine dose > 0.2 μg/kg/min + dobutamin dose > 5 μg/kg/min + (LVEF < 35% or LVEF 35-55% + severe mitral regurgitation or aortic stenosis)
- Metabolic:
Show all 9Show fewer
- Lactate - two consecutive values ≥ 3 mmol/L (with at least 30 min between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors or SvO2 - two consecutive values < 50% (with at least 30 min between measurements), with non-increasing trend on steady doses of inotropes and/or vasopressors
- Hypovolemia must be excluded:
- Central venous pressure > 7 mmHg or pulmonary capillary wedge pressure > 12 mmHg
Who cannot join
- Age < 18 years
- Life expectancy lower than 1 year
- High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock
- Significant bradycardia or tachycardia which might be responsible for hemodynamic instability and not treated by pacing or cardioversion
- Cardiac arrest survivors remaining comatose
- Hypertrophic obstructive cardiomyopathy
Show all 11Show fewer
- Peripheral artery disease disabling insertion of outflow cannula to femoral artery
- Moderate to severe aortic regurgitation
- Aortic dissection
- Uncontrolled bleeding or TIMI major bleeding within last 6 months
- Known encephalopathy
Trial locations and contacts
4 sites in 1 country.
Czechia4 sites
Regional Hospital Liberec
Liberec
University Hospital Pilsen
Pilsen, 30460
Na Homolce Hospital
Prague, Select One, 15030
General University Hospital
Prague, 12808
About this study
Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group, all other diagnostic and therapeutic procedures will be done according to the current standard of care at the tertiary cardiovascular center, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of other mechanical support devices including ECMO in the primary conservative group is allowed in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and 12 months.
- Conditions
- Cardiogenic Shock
- Being tested
- Veno-arterial extracorporeal membrane oxygenation (ECMO), Early conservative therapy according to standard practice
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veno-arterial extracorporeal membrane oxygenation (ECMO)Device
Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.
Early conservative therapy according to standard practiceOther
Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Invasive | Active comparator | Immediate veno-arterial extracorporeal membrane oxygenation (ECMO) Receives: Device: Veno-arterial extracorporeal membrane oxygenation (ECMO) |
| Conservative | Active comparator | Early conservative therapy according to standard practice Receives: Other: Early conservative therapy according to standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Measured: 30 days
Secondary outcomes (4)
All-cause mortality
Measured: 30 days
All-cause mortality
Measured: 6 months
All-cause mortality
Measured: 12 months
Neurological outcome (according to Cerebral Performance Category scale)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2022
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Na Homolce Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague, University Hospital Pilsen
- Responsible party
- Principal investigator, Petr Ostadal, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301819
- Sponsor's protocol ID
- 25-5-14 V2
- Acronym
- ECMO-CS
- Status last verified
- Apr 2023
- First submitted
- 23 Nov 2014
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ostadal P, Rokyta R, Kruger A, Vondrakova D, Janotka M, Smid O, Smalcova J, Hromadka M, Linhart A, Belohlavek J. Extra corporeal membrane oxygenation in the therapy of cardiogenic shock (ECMO-CS): rationale and design of the multicenter randomized trial. Eur J Heart Fail. 2017 May;19 Suppl 2:124-127. doi: 10.1002/ejhf.857.
PubMed 28470919Ostadal P, Rokyta R, Karasek J, Kruger A, Vondrakova D, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Jarkovsky J, Svoboda M, Linhart A, Belohlavek J; ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.
PubMed 36335478Ostadal P, Vondrakova D, Rokyta R, Karasek J, Kruger A, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Linhart A, Belohlavek J. Cardiac index, SvO2 or pCO2 gap may determine benefit from ECMO in cardiogenic shock: post-hoc analysis of the multicenter, randomized ECMO-CS trial. Crit Care. 2025 Jul 14;29(1):303. doi: 10.1186/s13054-025-05513-5.
PubMed 40660350
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT02301819
- Acronym / sponsor ID
- ECMO-CS / 25-5-14 V2
- Conditions
- Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Na Homolce HospitalUniversity, hospital or other
- Collaborators
- General University Hospital, Prague, University Hospital Pilsen
- Study start
- Sep 2014
- Primary completion
- Aug 2022 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 26 Nov 2014 (estimated)
- 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.
Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group, all other diagnostic and therapeutic procedures will be done according to the current standard of care at the tertiary cardiovascular center, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of other mechanical support devices including ECMO in the primary conservative group is allowed in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive | Active comparator | Device: Veno-arterial extracorporeal membrane oxygenation (ECMO)Immediate veno-arterial extracorporeal membrane oxygenation (ECMO) |
| Conservative | Active comparator | Other: Early conservative therapy according to standard practiceEarly conservative therapy according to standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must fulfil criteria for rapidly deteriorating (A) or severe (B) cardiogenic shock:
- Rapidly deteriorating cardiogenic shock is defined as progressive hemodynamic instability necessitating repeated bolus administration of vasopressors to maintain mean arterial pressure > 50 mmHg + impaired left ventricle systolic function (Left ventricle ejection fraction (LVEF) < 35% or LVEF 35-55% in case of severe mitral regurgitation or aortic stenosis) or
- In severe cardiogenic shock all following criteria should be met:
- Hemodynamic:
- Cardiac Index (CI) < 2.2 L/min/m2 + norepinephrine dose > 0.1 μg/kg/min + dobutamin dose > 5 μg/kg/min or Systolic blood pressure < 100 mmHg + norepinephrine dose > 0.2 μg/kg/min + dobutamin dose > 5 μg/kg/min + (LVEF < 35% or LVEF 35-55% + severe mitral regurgitation or aortic stenosis)
Key exclusion criteria (11 listed)
- Age < 18 years
- Life expectancy lower than 1 year
- High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock
- Significant bradycardia or tachycardia which might be responsible for hemodynamic instability and not treated by pacing or cardioversion
- Cardiac arrest survivors remaining comatose
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 |
|---|---|---|
| Veno-arterial extracorporeal membrane oxygenation (ECMO)Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion. | Device | Invasive |
| Early conservative therapy according to standard practiceStandard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion. | Other | Conservative |
Primary outcome
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Time frame: 30 days
4 secondary outcomes
All-cause mortality
Time frame: 30 days
All-cause mortality
Time frame: 6 months
All-cause mortality
Time frame: 12 months
Neurological outcome (according to Cerebral Performance Category scale)
Time frame: 30 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 5 Apr 2023.
- Background: PubMed 28470919Ostadal P, Rokyta R, Kruger A, Vondrakova D, Janotka M, Smid O, Smalcova J, Hromadka M, Linhart A, Belohlavek J. Extra corporeal membrane oxygenation in the therapy of cardiogenic shock (ECMO-CS): rationale and design of the multicenter randomized trial. Eur J Heart Fail. 2017 May;19 Suppl 2:124-127. doi: 10.1002/ejhf.857.
- Results publication: PubMed 36335478Ostadal P, Rokyta R, Karasek J, Kruger A, Vondrakova D, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Jarkovsky J, Svoboda M, Linhart A, Belohlavek J; ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.
- Derived from this study: PubMed 40660350Ostadal P, Vondrakova D, Rokyta R, Karasek J, Kruger A, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Linhart A, Belohlavek J. Cardiac index, SvO2 or pCO2 gap may determine benefit from ECMO in cardiogenic shock: post-hoc analysis of the multicenter, randomized ECMO-CS trial. Crit Care. 2025 Jul 14;29(1):303. doi: 10.1186/s13054-025-05513-5.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiogenic Shock
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veno-arterial extracorporeal membrane oxygenation (ECMO) and Early conservative therapy according to standard practice in people with Cardiogenic Shock, run by Na Homolce Hospital at 4 sites in Czechia.
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 9 inclusion and 11 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. 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?
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device (time frame: 30 days). 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 NCT02301819, which also lists 3 linked publications.
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 5 Apr 2023.