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ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock (ECMO-CS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 23, 2014
First Posted Date  ICMJE November 26, 2014
Last Update Posted Date August 21, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
Official Title  ICMJE ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiogenic Shock
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Invasive
    Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)
    Intervention: Device: Veno-arterial extracorporeal membrane oxygenation (ECMO)
  • Active Comparator: Conservative
    Early conservative therapy according to standard practice
    Intervention: Other: Early conservative therapy according to standard practice
Publications * Ostadal P, Rokyta R, Kruger A, Vondrakova D, Janotka M, Smíd O, Smalcova J, Hromadka M, Linhart A, Bělohlávek 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petr Ostadal, MD, PhD +420257272208 ostadal.petr@gmail.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02301819
Other Study ID Numbers  ICMJE 25-5-14 V2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Petr Ostadal, Na Homolce Hospital
Study Sponsor  ICMJE Na Homolce Hospital
Collaborators  ICMJE
  • General University Hospital, Prague
  • University Hospital Pilsen
Investigators  ICMJE Not Provided
PRS Account Na Homolce Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP