- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301819
ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock (ECMO-CS)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Liberec, Czechia
- Regional Hospital Liberec
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Pilsen, Czechia, 30460
- University Hospital Pilsen
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Prague, Czechia, 12808
- General University Hospital
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Select One
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Prague, Select One, Czechia, 15030
- Na Homolce Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Invasive
Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)
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Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.
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Active Comparator: Conservative
Early conservative therapy according to standard practice
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Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Time Frame: 30 days
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30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 30 days
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30 days
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All-cause mortality
Time Frame: 6 months
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6 months
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All-cause mortality
Time Frame: 12 months
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12 months
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Neurological outcome (according to Cerebral Performance Category scale)
Time Frame: 30 days
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30 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-5-14 V2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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