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

Primary Purpose

Cardiogenic Shock

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Veno-arterial extracorporeal membrane oxygenation (ECMO)

Early conservative therapy according to standard practice

About this trial

This is an interventional treatment trial for Cardiogenic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Na Homolce Hospital
Regional Hospital Liberec
University Hospital Pilsen
General University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Invasive

Conservative

Arm Description

Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)

Early conservative therapy according to standard practice

Outcomes

Primary Outcome Measures

Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device

Secondary Outcome Measures

All-cause mortality

Neurological outcome (according to Cerebral Performance Category scale)

Full Information

NCT ID

NCT02301819

First Posted

November 23, 2014

Last Updated

April 3, 2023

Sponsor

Na Homolce Hospital

Collaborators

General University Hospital, Prague, University Hospital Pilsen

1. Study Identification

Unique Protocol Identification Number

NCT02301819

Brief Title

ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Acronym

ECMO-CS

Official Title

ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2022 (Actual)

Study Completion Date

January 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Na Homolce Hospital

Collaborators

General University Hospital, Prague, University Hospital Pilsen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Invasive

Arm Type

Active Comparator

Arm Description

Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)

Arm Title

Conservative

Arm Type

Active Comparator

Arm Description

Early conservative therapy according to standard practice

Intervention Type

Device

Intervention Name(s)

Veno-arterial extracorporeal membrane oxygenation (ECMO)

Intervention Description

Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.

Intervention Type

Other

Intervention Name(s)

Early conservative therapy according to standard practice

Intervention Description

Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.

Primary Outcome Measure Information:

Title

Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device

Time Frame

30 days

Secondary Outcome Measure Information:

Title

All-cause mortality

Time Frame

30 days

Title

All-cause mortality

Time Frame

6 months

Title

All-cause mortality

Time Frame

12 months

Title

Neurological outcome (according to Cerebral Performance Category scale)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Facility Information:

Facility Name

Na Homolce Hospital

City

Prague

State/Province

Select One

ZIP/Postal Code

15030

Country

Czechia

Facility Name

Regional Hospital Liberec

City

Liberec

Country

Czechia

Facility Name

University Hospital Pilsen

City

Pilsen

ZIP/Postal Code

30460

Country

Czechia

Facility Name

General University Hospital

City

Prague

ZIP/Postal Code

12808

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28470919

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.

Results Reference

background

PubMed Identifier

36335478

Citation

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.

Results Reference

result

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ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

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