ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock (ECMO-CS)
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ClinicalTrials.gov Identifier: NCT02301819 |
Recruitment Status :
Recruiting
First Posted : November 26, 2014
Last Update Posted : August 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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Cardiogenic Shock | Device: Veno-arterial extracorporeal membrane oxygenation (ECMO) Other: Early conservative therapy according to standard practice | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Invasive
Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)
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Device: 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. |
Active Comparator: Conservative
Early conservative therapy according to standard practice
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Other: Early conservative therapy according to standard practice
Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion. |
- Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device [ Time Frame: 30 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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)
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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:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301819
Contact: Petr Ostadal, MD, PhD | +420257272208 | ostadal.petr@gmail.com |
Czechia | |
Na Homolce Hospital | Recruiting |
Prague, Select One, Czechia, 15030 | |
Contact: Petr Ostadal, MD, PhD +420257272208 ostadal.petr@gmail.com | |
Regional Hospital Liberec | Recruiting |
Liberec, Czechia | |
Contact: Jiri Karasek, MD +420485312632 jiri.karasek@nemlib.cz | |
University Hospital Pilsen | Recruiting |
Pilsen, Czechia, 30460 | |
Contact: Richard Rokyta, MD, PhD +420 377 103 343 rokyta@fnplzen.cz | |
General University Hospital | Recruiting |
Prague, Czechia, 12808 | |
Contact: Jan Belohlavek, MD, PhD +420 224 96 2687 jan.belohlavek@vfn.cz |
Responsible Party: | Petr Ostadal, Dr., Na Homolce Hospital |
ClinicalTrials.gov Identifier: | NCT02301819 |
Other Study ID Numbers: |
25-5-14 V2 |
First Posted: | November 26, 2014 Key Record Dates |
Last Update Posted: | August 21, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Shock, Cardiogenic Shock Pathologic Processes Myocardial Infarction |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |