NCT02301819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

7.9 years

First QC Date

November 23, 2014

Last Update Submit

April 3, 2023

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

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

    30 days

Secondary Outcomes (4)

  • All-cause mortality

    30 days

  • All-cause mortality

    6 months

  • All-cause mortality

    12 months

  • Neurological outcome (according to Cerebral Performance Category scale)

    30 days

Study Arms (2)

Invasive

ACTIVE COMPARATOR

Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)

Device: Veno-arterial extracorporeal membrane oxygenation (ECMO)

Conservative

ACTIVE COMPARATOR

Early conservative therapy according to standard practice

Other: Early conservative therapy according to standard practice

Interventions

Veno-arterial extracorporeal membrane oxygenation (ECMO)DEVICE

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

Invasive
Early conservative therapy according to standard practiceOTHER

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

Conservative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Na Homolce Hospital

Prague, Select One, 15030, Czechia

Location

Regional Hospital Liberec

Liberec, Czechia

Location

University Hospital Pilsen

Pilsen, 30460, Czechia

Location

General University Hospital

Prague, 12808, Czechia

Location

Related Publications (3)

  • 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.

    PMID: 28470919BACKGROUND

  • 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.

    PMID: 36335478RESULT

  • Ostadal P, Vondrakova D, Rokyta R, Karasek J, Kruger A, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Linhart A, Belohlavek J. Cardiac index, SvO2 or pCO2 gap may determine benefit from ECMO in cardiogenic shock: post-hoc analysis of the multicenter, randomized ECMO-CS trial. Crit Care. 2025 Jul 14;29(1):303. doi: 10.1186/s13054-025-05513-5.

    PMID: 40660350DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 23, 2014

First Posted

November 26, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2022

Study Completion

January 1, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

CZ(4)