Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

Helios Health Institute GmbH

Status: Active, not recruiting

Conditions: Cardiogenic Shock; Acute Myocardial Infarction

Treatments: Procedure: ECLS insertion; Other: Revascularisation and optimal medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03637205

HRC[045584]

Details and patient eligibility

About

The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality

Enrollment: 420 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
• Planned revascularization (PCI or alternatively CABG)
• Systolic blood pressure <90 mmHg >30 min or catecholamines required to maintain pressure >90 mmHg during Systole
• Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output <30 ml/h
• Arterial lactate >3 mmol/l
• Informed consent

Exclusion criteria

• Resuscitation >45 minutes
• Mechanical cause of cardiogenic shock
• Onset of shock >12 h
• Severe peripheral artery disease with impossibility to insert ECLS cannulae
• Age <18 years or age >75 years
• Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
• Other severe concomitant disease with limited life expectancy <6 months
• Pregnancy
• Participation in another trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

ECLS

Experimental group

Description:

PCI (or CABG) plus medical treatment + ECLS

Treatment:

Other: Revascularisation and optimal medical treatment

Procedure: ECLS insertion

No ECLS

Active Comparator group

Description:

PCI (or CABG) plus medical treatment

Treatment:

Other: Revascularisation and optimal medical treatment