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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
Sponsor:
Collaborators:
General University Hospital, Prague
University Hospital Pilsen
Information provided by (Responsible Party):
Petr Ostadal, Na Homolce Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: Veno-arterial extracorporeal membrane oxygenation (ECMO) Other: Early conservative therapy according to standard practice Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Invasive
Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)
 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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]
  2. All-cause mortality [ Time Frame: 6 months ]
  3. All-cause mortality [ Time Frame: 12 months ]
  4. Neurological outcome (according to Cerebral Performance Category scale) [ Time Frame: 30 days ]

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

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:

  1. 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)

  2. 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

  3. Hypovolemia must be excluded:

Central venous pressure > 7 mmHg or pulmonary capillary wedge pressure > 12 mmHg

Exclusion Criteria:

  1. Age < 18 years
  2. Life expectancy lower than 1 year
  3. High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock
  4. Significant bradycardia or tachycardia which might be responsible for hemodynamic instability and not treated by pacing or cardioversion
  5. Cardiac arrest survivors remaining comatose
  6. Hypertrophic obstructive cardiomyopathy
  7. Peripheral artery disease disabling insertion of outflow cannula to femoral artery
  8. Moderate to severe aortic regurgitation
  9. Aortic dissection
  10. Uncontrolled bleeding or TIMI major bleeding within last 6 months
  11. Known encephalopathy
Contacts and Locations
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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


Contacts
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Contact: Petr Ostadal, MD, PhD +420257272208 ostadal.petr@gmail.com

Locations
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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   
Sponsors and Collaborators
Na Homolce Hospital
General University Hospital, Prague
University Hospital Pilsen
More Information
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Publications:

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Responsible Party: Petr Ostadal, Dr., Na Homolce Hospital
ClinicalTrials.gov Identifier: NCT02301819     History of Changes
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
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases