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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
| University Hospital Pilsen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invasive | Active Comparator | Immediate veno-arterial extracorporeal membrane oxygenation (ECMO) |
|
| Conservative | Active Comparator | Early conservative therapy according to standard practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days | |
| All-cause mortality | 6 months | |
| All-cause mortality |
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Inclusion Criteria:
Patients must fulfil criteria for rapidly deteriorating (A) or severe (B) cardiogenic shock:
A. 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
B. 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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | Select One | 15030 | Czechia | ||
| Regional Hospital Liberec |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28470919 | Background | 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. | |
| 36335478 |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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| Early conservative therapy according to standard practice | Other | Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion. |
|
| 12 months |
| Neurological outcome (according to Cerebral Performance Category scale) | 30 days |
| Liberec |
| Czechia |
| University Hospital Pilsen | Pilsen | 30460 | Czechia |
| General University Hospital | Prague | 12808 | Czechia |
| Ostadal 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. |
| 40660350 | Derived | Ostadal 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |