ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    120
  • sponsor
    Na Homolce Hospital
Updated on 19 September 2021
systolic blood pressure
percutaneous coronary intervention
dobutamine
vasopressor
norepinephrine
serum lactate
aortic stenosis
membrane oxygenation
inotropic agent

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.

Details
Condition Cardiogenic shock
Treatment Veno-arterial extracorporeal membrane oxygenation (ECMO), Early conservative therapy according to standard practice
Clinical Study IdentifierNCT02301819
SponsorNa Homolce Hospital
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must fulfil criteria for rapidly deteriorating (A) or severe (B)
cardiogenic
shock
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
In severe cardiogenic shock all following criteria should be met
Hemodynamic
Cardiac Index (CI) < 2.2 L/min/m2 + norepinephrine dose > 0.1 g/kg/min +
dobutamin dose > 5 g/kg/min or Systolic blood pressure < 100 mmHg +
norepinephrine dose > 0.2 g/kg/min + dobutamin dose > 5 g/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
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