ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Cardiogenic Shock Clinical Trial

— ECMO-CS  

Official title:

ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301819
• Other study ID #: 25-5-14 V2
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 2023

Study information

• Verified date: April 2023
• Source: Na Homolce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

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.

Locations

Country	Name	City	State
Czechia	Regional Hospital Liberec	Liberec
Czechia	University Hospital Pilsen	Pilsen
Czechia	General University Hospital	Prague
Czechia	Na Homolce Hospital	Prague	Select One

Sponsors (3)

Lead Sponsor	Collaborator
Na Homolce Hospital	General University Hospital, Prague, University Hospital Pilsen

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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 Ther — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device		30 days
Secondary	All-cause mortality		30 days
Secondary	All-cause mortality		6 months
Secondary	All-cause mortality		12 months
Secondary	Neurological outcome (according to Cerebral Performance Category scale)		30 days